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Ministry of Health - MS
National Health Surveillance Agency - ANVISA

COLLEGIATE BOARD RESOLUTION - RDC No. 528, OF AUGUST 4, 2021

(Published in DOU No. 151, of August 11, 2021)

Provides for the list of preservative substances

allowed for personal hygiene products, cosmetics
and perfumes and internalizes Resolution GMC
MERCOSUR nº 35/20.

The Collegiate Board of the National Health Surveillance Agency, in the use of the
attributions conferred by art. 15, III and IV, combined with art. 7, III and IV of Law No. 9,782, of
January 26, 1999, and art. 53, VI, §§ 1 and 3 of the Internal Regulation approved by the Resolution
of the Collegiate Board of Directors - RDC No. 255, of December 10, 2018, resolves to adopt the
following Resolution, as resolved at a meeting held on August 4, 2021, and I , Chief Executive
Officer, I determine its publication.

Art. 1 This Resolution provides for the list of preservative substances allowed for personal
hygiene products, cosmetics and perfumes.

Art. 2 This Resolution incorporates Resolution GMC MERCOSUR nº 35/20 to the

national legal order.

Art. 3 For the purposes of this Resolution, the following definitions are adopted:

I. - preservatives: are substances that are added as an ingredient to personal hygiene

products, cosmetics and perfumes in order to inhibit the growth of microorganisms during their
manufacture and storage or to protect the products from inadvertent contamination during use;

II. - salts: salts of sodium, calcium, potassium, magnesium, ammonium and

ethanolamines; and salts of chloride, bromide, sulfate and acetate anions;

III. - esters: methyl, ethyl, propyl, isopropyl, butyl, isobutyl and phenyl esters;

IV. - rinse-off products: any personal hygiene product, cosmetic or perfume intended to be
removed, with water or another solvent, after application;

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V. - products that do not rinse off: any personal hygiene product, cosmetic or perfume intended to remain
in prolonged contact with the application site; It is

SAW. - products for oral use: any product that is applied to the teeth and/or
mucosa of the oral cavity, therefore they do not include products applied on the lips.

Art. 4 Preservatives with the (*) symbol can also be used for other specific purposes, subject to the
conditions and concentration limits established in other lists, if any.

Single paragraph. If the preservative with the (*) symbol is not on the restrictive list or belongs to any other
list, it may be used with other functions or concentrations whenever scientifically proven.

Art. 5 Preservatives that do not have the symbol (*) may be used for purposes other than preservative,
provided that the concentrations, limitations, conditions of use and warnings established in this Resolution are
respected.

Art. 6 Other substances used in the formulation of personal hygiene products, cosmetics and perfumes
may have antimicrobial properties and may, therefore, contribute to the conservation of these products, such as,
for example, certain essential oils and certain alcohols, but are not covered by this Resolution.

Art. 7 The association of preservative substances is allowed, respecting the limits

of each preservative and the conditions foreseen for some mixtures.

Art. 8 The restriction on sprayable systems applies to forms of presentation that generate particles in the
air, for example, “aerosols”, “ sprays”, “pumps” and “squeezes”.

Single paragraph. For aerosols that do not release particles into the air, eg mousse or shaving cream, the
restriction on sprayable systems does not apply.

Art. 9 The columns with the INCI nomenclatures and CAS numbers of each ingredient or group of
ingredients do not include all existing INCI nomenclatures and CAS numbers, and there may be others that are
not included in this Resolution.

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Art. 10. The value of decimal places not expressed for concentrations present in this
Resolution is “zero”.

Art. 11. Failure to comply with the provisions contained in this Resolution constitutes a
sanitary infraction, under the terms of Law No. 6,437, of August 20, 1977, without prejudice to
applicable civil, administrative and criminal responsibilities.

Art. 12. A period of thirty-six (36) months is established for the adaptation of products that are regularized
in accordance with the Resolution of the Collegiate Board -
RDC No. 29, of June 1, 2012, counted from the entry into force of this Resolution.

Single paragraph. Products manufactured in accordance with the Resolution of the

Collegiate Board of Directors - RDC No. 29, of June 1, 2012, before the adequacy of the
regularization and within the period established by the caput, may be sold until the end of
their validity periods .

Art. 13. Resolution of the Collegiate Board of Directors - RDC No. 29, of June 1, 2012,
published in the Official Gazette of the Union No. 107, of June 4, 2012, Section 1, pg. 81.

Art. 14. This Resolution enters into force on the date of its publication.

ANTONIO BARRA TORRES

CEO

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ATTACHMENT

LIST OF SUBSTANCES WITH PRESERVATIVE ACTION PERMITTED FOR PRODUCTS OF

PERSONAL HYGIENE, COSMETICS AND PERFUMES

CONCENTRATION CONDITIONS OF
WOMEN

SUBSTANCE PEARL CAS MAXIMUM LIMITATIONS USE E

ORDER
AUTHORIZED WARNINGS

a) 2.5% (expressed
as acid) in rinse-off
products, except
products for oral
use.

BENZOIC
Benzoic acid and its b) 1.7% (expressed
ACID/ 65-85-0/
1 sodium salt (*) as
SODIUM 532-32-1
acid) in
BENZOATE
products for oral use.

c) 0.5% (expressed
as acid) in leave-on
products.

AMMONIUM 1863-63-
BENZOATE/ 4/
BUTYL 2090-05-
BENZOATE/ 3/
CALCIUM 582-25-2/
acid salts BENZOATE/
553-70-8/
benzoic acid not ETHYL
4337-66-
included in order number BENZOATE/ 0.5% (expressed
2 0/
1 and ISOBUTYL as acid)
93-58-3/
benzoic acid esters BENZOATE/
93-89-0/
ISOPROPYL
BENZOATE/
2315-68-
MAGNESIUM
6/
BENZOATE/
136-60-7/
MEA-BENZOA
1205-50-
TE/METHYL

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BENZOATE/ 3

PHENYL
BENZOATE/
POTASSIUM
BENZOATE/

PROPYL /
BENZOATE 939-48-0/
93-99-2
PROPIONIC 79-09-4/
ACID/BUT 17496-08
NIUM -1/
PROPIONATE/ 4075-81-
CALCIUM 4

propionic acid and PROPIONATE/ / 2.0% (expressed

3
your salts MAGNESIUM 557-27-7/ as acid)
PROPIONATE/
POTASSIUM
327-62-8/
PROPIONATE/
137-40-6
SODIUM
PROPIONATE

a)SALICYLIC a) a) -Forbidden
a) -For
ACID 69-72-7 in
products for adult
products
use: "No
b) CALCIUM for
use on
SALICYLATE/ children
under
b)
MAGNESIUM 3 years.
824-35-1/
SALICYLATE/ - Prohibited
18917-89 a) and b) 0.5%
Salicylic acid and its MEA-SALICYL in children".
4 -0/ (expressed as acid)
salts (*) ATE/ -For products
59866-70 products
SODIUM intended for
-5/ for oral
SALICYLATE/ use. children: "Do not
54-21-7/
POTASSIUM - Prohibited use in
578-36-9/
SALICYLATE/T in children
2174-16-
EA-SALICYLAT minors
5 products
AND

whose

application

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can
lead to
exposure
via the
inhalation route.
b) prohibited
in

products
3 years”.
for
b)-For products for
children
adult use:
under
"Do not use in
3 years, with
children".
the exception of
shampoos
with

rinse.

-For products
intended for
children, except for

rinse-off
shampoos: "Do not
use in children under
3 years old”.

110-44-1/
SORBIC ACID/
7492-55-
CALCIUM
9/
SORBATE/
sorbic acid and 7757-81- 0.6% (expressed
5 SODIUM
your salts 5 as acid)
SORBATE/
/
POTASSIUM
24634-61
SORBATE
-5

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sorbate 0.6% (expressed as

6 TEA-SORBATE
Triethanolamine (*) acid)
a) 0.2% (expressed as
phenol) in rinse-off
products.
Prohibited the
Biphenyl-2-ol O-PHENYLPHE know of avoid contact
7 90-43-7
(o-phenylphenol) NOL b) 0.15% (expressed o-phenylph with the eyes.
as enol.

phenol) in products that

do not rinse off.

8 excluded
SODIUM

SULFITE/
7757-83-
AMMONIUM
7/
BISULFITE/
10192-30
AMMONIUM
-0/
SULFITE/
10196-04
POTASSIUM
-

SULFITE/
POTASSIUM
HYDROGEN

SULFITE/
SODIUM
0/
Inorganic sulfites and 0.2% (expressed as
BISULFITE/ 10117-38
9 bisulfites (*) free SO2)
SODIUM
-1/
METABISULFI 7773-03-
THE/
7/
POTASSIUM 7631-90-
METABISULFI 5
THE

/
7681-57-

4/
16731-55
-8
10 1,1,1-Tricloro-2-me CHLOROBUTA 57-15-8 0,5% Prohibited in Contains

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tilpropanol-2-(cloro NOL systems clorobutanol.

butanol) sprayable
s (such
as aerosols and
sprays).
4-HYDROXYBE
NZOIC ACID/
METHYLPARA 99-96-7/ -0.4% (expressed
BEN/ 99-76-3/ as acid) for each
POTASSIUM 36457-19 substance
ETHYLPARABE -9/ considered
N/ 16782-08 individually.
POTASSIUM -

Forbidden:
PARABEN/
isopropilpar
SODIUM
abeno,
METHYLPARA -0.8% (expressed
4- isobutylpara
4/
BEN/ as acid) for the sum of
Hydroxybenzoic acid, 5026-62- beno,
SODIUM
11 its methyl and ethyl fenilparabe
0/
ETHYLPARABE
esters, and its salts 35285-68 no,
N/
-8/ benzylparab
ETHYLPARABE
individual that's it
120-47-8/
N/SODIUM concentrations of pentilparab
114-63-6/ 4-p- one.
26112-0-
PARABEN/ hydroxybenzoic acid
POTASSIUM 2/
o, their methyl and
69959-44
METHYLPARA ethyl esters and their
-0
BEN/ salts contained in
CALCIUM the product.
PARABEN

BUTYLPARABE -0.14% (expressed Do not use In leave-on

Butyl 4-hydroxybenzoate N/ as acid) for the sum of in products
94-26-8/
and its salts PROPYLPARAB individual non-rinse designed for
94-13-3/
IN/ concentrations. products children
35285-69
SODIUM intended for
11-A -9/
Propyl 4-hydroxybenzoate PROPYLPARAB the minors
36457-20
and its salts IN/ -0.8% (expressed
-
3 years: "Do not
SODIUM as acid) for the diapers in
use in areas
BUTYLPARABE sum of This text children

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N/ individual under of diapers”.

POTASSIUM concentrations of 3 years.
BUTYLPARABE the substances
2/
N/ mentioned in the
38566-94
POTASSIUM items 11 and 11-A
-8/
PROPYLPARAB contained in the
IN product; in this
case to soma

of the individual
concentrations of butyl
It is

84930-16
propylparaben and its
-5
salts must not

exceed 0.14%
(expressed as acid).

prohibited in
DEHYDROACE 520-45-6/
sprayable
TIC ACID/ 4418-26-
0.6% (expressed as systems
12 Dehydroacetic acid SODIUM 2/
acid) s (such as
and its salts DEHYDROACE 16807-48
aerosols and
TATE -0
sprays).
FORMIC ACID/
Formic acid and its 64-18-6/ 0.5% (expressed as
13 SODIUM
sodium salt 141-53-7 acid)
FORMATS

3,3’-Dibromo – 4,4’
hexamethylenedioxy
DIBROMOHEX
dibenzamidine (dibr 93856-83
14 AMIDINE 0,1%
omohexamidine) and -8
ETHIONATE
their salts (including
isothionate)
15 Excluded
16 Excluded
UNDECYLENIC
112-38-9/
Undecanoic acid-10-in ACID/
6159-41-
o (undecylene), its POTASSIUM 0.2% (expressed as
17 7/
salts, esters, amines and UNDECYLENA acid)
3398-33-
THE/
2
sulfosuccinato SODIUM

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UNDECYLENA
THE/

CALCIUM
UNDECYLENA /
THE/ 1322-14-
MY-UNDECY 1

LENATE/
TEA-UNDECYL /
ENATE 84471-25
-0/
56532-40
-2

Amino-5-bis(ethyl-2-
hexyl)-1,3
18 HEXETIDINE 141-94-6 0,1%
methyl-5-perhydropyr
boring
-Prohibited
in

non-rinse
products.
5-BROMO-5-N
5-bromo-5-nitro-1, 30007-47
19 ITRO-1,3-DIOX 0,1%
3 dioxano -7 -Avoid
HAS
nitrosamine

formation
s.

Avoid

2-bromo-2-nitropr 2-BROMO-2-N formation of

20 opano-1,3-diol ITROPROPANE 52-51-7 0,1%
(Bronopol) -1,3-DIOL nitrosamina
s.

- Criterion of

pureza:
3,3’,4,4’-Tet
3,4,4'-trichlorocarba TRICLOCARBA
21 101-20-2 0,2% raclor-azo
nilida (*) N
benzene

less than 1
ppm and

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3,3’,4,4’-Tet
racloro-azox
activity

less than 1ppm.

prohibited in

destined
products
P-CHLORO-M
22 p-chloro-methacresol 59-50-7 0,2% to enter
CRESOL
contact
with
mucous membranes.

CHLOROXYL 88-04-0/1
23 p-chloro-metaxylenol 0,5%
NOL 321-23-9
IMIDAZOLIDIN 39236-46
Imidazolidinil urea 0,6%
24 YL UREA -9
Prohibited in

products
32289-58
-0/27083-
Polyhexamethylene POLYAMINOP whose application
27-8/287
25 biguanide hydrochloride ROPYL 0,1% can
57-47-3/1
BIGUANIDE lead to
33029-32
exposure via
-0
the inhalation
route.
PHENOXYETH
26 2- Phenoxyethanol 122-99-6 1,0%
ANOL
Prohibited in
CHLOROTHYM
27 6-Clorotimol 89-68-9 0,1% children's
OL
products.
28 Excluded

a) 0.5% in rinse-off
shampoos.
1-(4-chlorophenoxy)-1-
(1-Imidazolil)-3,3-in 38083-17 b)0.2% in face creams,
29 CLIMBAZOLE
methyl-2-butanone (* -9 hair lotions and
) foot care products.

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1,3-Dimethylol-5,5-di DMDM 6440-58-

30 0,6%
methyl hydantoin HYDANTOIN 0

PHENETHYL
31 2-Phenylethanol 60-12-8 1,0%
ALCOHOL
BENZYL
32 Benzilic alcohol (*) 100-51-6 1,0%
ALCOHOL
1-hydroxy-4-methyl-6- a) 1% in rinse-off products.
(2,4,4-trimetilpentil 50650-76

)-2-pyridone and its PIROCTONE -5/

33
OLAMINE 68890-66 b) 0.5% on
monoethanolamine salts -4 products that do not
(Octopirox) rinse off.
3228-02-

4-Isopropyl-m-cresus O-CYMEN-5-O 2/
34 0,1%
l L 39660-61
-2

26172-55 -Prohibited
-4/ in
2682-20- no-rinse
4 products
0.0015% (from a 3:1
(including
mixture of
wet wipes

5-Chloro-2-methyl
Mixture of 5- isothiazol-3(2H)-on
).
chloro-2-methyl-4-ions / of 2-
METHYLCHLO -The use of the
otiazolina-3-one is 2- 55965-84 Methylisothiazol-3
ROISOTHIAZO mixture
methyl-4-isothiazo -9 (2H)-one)
LINONE e de
35 lin-3-one with
METHYLISOTH methylchlor
magnesium
IAZOLINONE isothiazoles
chloride and magnesium
none e
nitrate (3:1)
methylisothi
azolinone is

incompatible
in rinse-off products. l as a

use of methylisothi

azolinone
alone in

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one same

product.

36 Excluded
37 Excluded
CHLORHEXIDI

NE/
CHLORHEXIDI
NO
55-56-1/
Bis-(p-chlorofenildig DIACETATE/
56-95-1/
uanide)-1,6-hexane and its CHLORHEXIDI
18472-51 0.3% (expressed as
38 acetate, gluconate NO
-0/ chlorhexidine)
and hydrochloride DIGLUCONAT
3697-42-
AND/
5
CHLORHEXIDI
NO
DIHYDROCHL
ORIDE
Prohibited in

1-Phenoxy-2-propane PHENOXYISOP non-rinse

39 770-35-4 1,0%
ol (*) ROPANOL products.

prohibited in

products
4,4-Dimethyl-1,3-oxa DIMETHYL 51200-87
40 0,1% with a pH
zolidina OXAZOLIDINE -4
equal to
or less than 6.

N-(hydroxymethyl)-N-
(dihydroxymethyl-1,3-
DIAZOLIDINYL 78491-02
41 dioxo-2,5-imidazolium 0,5%
UREA -8
dinyl-4)-N'(hydroxym
ethyl urea
contains
prohibited in
glutaraldehyde
sprayable
(only for
systems
42 glutaraldehyde GLUTARAL 111-30-8 0,1% concentrations
s (such as
greater than
aerosols and
0.05% in the
sprays).
product

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finish).

Prohibited in

products
for oral use
5-Ethyl-3,7-dioxa-1- 7-ETHYLBICYC and in products
7747-35-
43 azabiciclo(3.3.0) LOOXAZOLIDES 0,3% that come
5
octane NO into contact

with
mucous membranes.

6.6-dibromo-4.4-in
BROMOCHLO 15435-29
44 chloro-2,2'-methylene 0,1%
ROPHENE -7
difenol
DICHLOROBE
Alcohol 2,4- 1777-82-
45 NZYL 0,15%
Dichlorobenzílico 8
ALCOHOL

a) 0.3% in -Prohibited
toothpastes, on systems

hand soaps, soaps sprayable

s (such as
for the aerosols and

body/corpora gels sprays).

is for
Trichloro-2,4,4'
3380-34- bath, deodorant -Prohibited or
46 hydroxy-2' TRICLOSAN
5 is use in
diphenyl ether
others
for underarms and
products
feet, face powders
that were
and concealers and nail
not
care products before
nail application detailed in

items a)

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artificial. e b).
b) 0.2% in
mouthwashes.

Hexamethylenetetra METHENAMI
47 100-97-0 0,15%
mine NO
BEHENTRIMO
NIUM

CHLORIDE (*)/ 17301-53

QUATRIMONY -0/
M BROMIDE/ 57-09-0/
QUATRIMONY 112-02-7/
M

CHLORIDE(*)/
LAURTRIMONI 1119-94-
Bromide and Chloride
ONE 4/
48 Alkyl (C12-C22) 0,1%
BROMIDE/
trimethylammonium
LAURTRIMONI
ONE

CHLORIDE/ 112-00-5/
STEARTRIMO 1120-02-
NIUM
1/
BROMIDE/ 112-03-8
STEARTRIMO
NIUM

CHLORIDE (*)

HEXAMIDINE/
HEXAMIDINE 3811-75-
1,6-di-(4-amidinophe
DIISETHIONAT 4/
noxy)-n-hexane and its
AND/ 659-40-5/
salts (including isothionate 0,1%
49 HEXAMIDINE 93841-83
and p-
DIPPED/ -9/
hydroxybenzoate)
HEXAMIDINE -

PARABEN

3-(p-chlorophenoxy)-p CHLORPHENE
50 104-29-0 0,3%
ropano-1,2-diol SIN
SODIUM
hydroxymethylamino 70161-44
51 HYDROXYMET 0,5%
sodium acetate -3
HYLGLYCINAT

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AND

-20% AgCl
(p/p) em
TiO2.
-Prohibited
in

products
for
children
under
Silver chloride 0.004% (expressed 3 years,
SILVER 7783-90-
52 deposited on titanium as chloride of in
CHLORIDE 6
dioxide talk) products
for oral
use, in
products
for the eye
area and
in

lip products.

8001-54-
5/
63449-41
-2/
91080-29
BENZALKONIA -

M CHLORIDE/ 4/
(C8-C18)alkyl
BENZALKONIA 68989-01
0.1% (expressed
M BROMIDE/ -5/ Avoid eye contact.
53 as benzalkonium
BENZALKONIA 68424-85
dimethylbenzylammonium chloride, bromide and saccharin chloride)
M -1/
O (*)
SACCHARINAT 68391-01
AND
-5/
61789-71
-

7/
85409-22
-9

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prohibited in
BENZYLHEMIF 14548-60 non-rinse
54 Benzylhemiformal 0,15%
ORMAL -8 products.

a) 0.02% in a), b) ec)

rinse-off products. prohibited in
products
a) -For
for oral
products for adult
use and
use: "No
products
use on
for the
children".
lips.
-For products
a) prohibited
in
b) 0.01% in
destined
products that do not
products
rinse off,
to children
except in
under
deodorants and/or
3 years, intended for
antiperspirants.
excluding bath/ children:
IODOPROPYN dimmer "Do not use in
3-iodo-2-propynylbu YL 55406-53 products children
55 tilcarbamate BUTYLCARBA -6 are gel and under 3 years
DEATH soap old"
bath
body liquid

c) 0.0075% in
and shampoo.
deodorants and/or (this
b) Prohibited
antiperspirants. warning does not
in lotions and
apply to bath/
creams
soak products,
bodily or any
gels, and soaps

other
product body fluid for bath
intended for and shampoo).
application
in large body b) ec)
extension; -For products for
adult use:

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prohibited in "Do not use in

products children".
for -For products
children intended for
under Children public:
3 years. "Do not use in
c) Prohibited
in

products
for

children
under children
3 years. under 3
years".

Prohibited in
chloride of products
Diisobutil BENZETHONI for oral
56 121-54-0 0,1%
fenoxyetoxyethyl-dim A CHLORIDE use that do
ethyl-benzylamônio not
rinse.
-Prohibited
in

no-rinse
products
(including
wet wipes

0.0015% in
2-methyl-4-isothiazoles METHYLISOTH 2682-20-
rinse-off products. ).
57 on-3-she IAZOLINONE 4
-The use of the
mixture
de
methylchlor
isothiazoles
none e
methylisothi
azolinone is

This text does not replace the one(s) published in the Official Gazette.
Machine Translated by Google

Ministry of Health - MS
National Health Surveillance Agency - ANVISA

incompatible
l with
the use of
methylisothi
azolinone
alone in
one same
product.
a) prohibited
in

products
for
kids.
b) Prohibited
in product
s for lips,
products
a) 0.15% in
hydrochloride of mouthwashes.
ETHYL for oral
ethyl-N- 60372-77 a) Do not use in
58 LAUROYL use
ÿ-dodecanoil-L-argi -2 children.
ARGINATE HCl (except
nato (*) b) 0.4% in other
mouthwashes)
products.
you

buccal
following item
"a") and in
sprayable
systems
s (like
sprays
and aerosols).
1,2,3-
propanotricar acid Prohibited in
boxylic, products
2-hydroxy-, CITRIC ACID 0.2%, for buccal
59 monohydrate and e SILVER -
corresponding to use and in
1,2,3- acid CITRATE 0.0024% silver. products
propanotricarboxíli for the eye
co, 2-hydroxy-, area.
silver salt(1+), This
text does not replace the one(s) published in the Official Gazette.
Machine Translated by Google

Ministry of Health - MS

National Health Surveillance Agency - ANVISA

monohydrate
HYDROXYETH
4-(3-ethoxy-4-hydroxy 569646-7
60 OXYPHENYL 0,7%
phenyl)butan-2-one 9-3
BUTANONE

This text does not replace the one(s) published in the Official Gazette.