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Cosmetic Dossier

This document summarizes the results of testing a cosmetic product for skin irritation potential. In a study of 25 volunteers: - The product was applied to the skin for 48 hours. - Readings taken at 30 minutes, 24 hours, and 48 hours found no evidence of erythema, edema, scaling, itching, or burning in any volunteers. - The product is considered to have no skin irritation potential based on the lack of adverse effects seen in this study.

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0% found this document useful (0 votes)
795 views8 pages

Cosmetic Dossier

This document summarizes the results of testing a cosmetic product for skin irritation potential. In a study of 25 volunteers: - The product was applied to the skin for 48 hours. - Readings taken at 30 minutes, 24 hours, and 48 hours found no evidence of erythema, edema, scaling, itching, or burning in any volunteers. - The product is considered to have no skin irritation potential based on the lack of adverse effects seen in this study.

Uploaded by

threwaway
Copyright
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We take content rights seriously. If you suspect this is your content, claim it here.
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You are on page 1/ 8

Cosmetic dossier (Product Information File)

MATERIAL SAFETY DATA SHEET.

SECTION 1 - CHEMICAL SUBSTANCE/PRODUCT AND COMPANY


IDENTIFICATION

Finished Product Name: NEXUS CREAM

Company Identification: Peer Pharm Ltd.


Amal 17st. Afek Industry Park. Rosh-Ha Ayin 48092 Israel

DATE: March 2013

SECTION 2 - HAZARDS IDENTIFICATION

EMERGENCY OVERVIEW:
This is a personal care or cosmetic product that is safe for consumers and other users under
intended and reasonably foreseeable use. Additional information on toxicological endpoints is
available from the supplier upon request.

POTENTIAL HEALTH EFFECTS:


Eye:
Contact may cause mild, transient irritation. Some redness and/or stinging may occur.
Skin:
Not expected to be irritating, sensitizing, photoallergenic or phototoxic when used as intended.
If irritation occurs following intended use or prolonged contact it is expected to be mild and
transient.
Inhalation:
Not expected to be irritating to the respiratory system. Not volatile therefore limited inhalation
exposure anticipated.
Ingestion:
Product used as intended is not expected to cause gastrointestinal irritation. Accidental ingestion
of undiluted product may cause mild gastrointestinal irritation with nausea, vomiting and
diarrhea.

SECTION 3 - COMPOSITION AND INGREDIENTS

,Triglyceride,glycerin Caprylic/Capric ,Isopropyl Myristate ,oil )bergamot( bergamia Citrus ,Water


,Stearate se glyceryl ,Cetyl alcohol ,Lanolin ,Allantoin, Propylene glycol
D-panthenol ,Silt extract ,Salicylic acid,dimethicon ,Dehydroacetic Acid, Benzoic Acid, Benzyl
alcohol,Aloe Barbadensis( Aloe )Leaf Juice,silica,betain, fragrance,, Bisabolol ,Dipotassium
Glycyrrhizate
SECTION 4 - FIRST AID MEASURES

Eye:
Thorough rinsing for 15-20 minutes of the affected eye with water is recommended. If
discomfort or irritation persists, contact a physician.
Skin Problem:
Discontinue use of product. Apply cold compresses to affected areas to relieve any discomfort.
If discomfort persists, contact a physician.
Inhalation:
If respiratory irritation occurs, remove individual to fresh air.
Ingestion:
Accidental ingestion of product may necessitate medical attention. In case of accidental
ingestion dilute with fluids (water or milk) and treat symptomatically. Do not induce vomiting.
Note: After first aid treatment, the caller should be advised that 1) a hospital emergency room or
family physician should be consulted if anything unusual occurs or appears necessary in the
judgment of the caller, and 2) that the subsequent management of the accident should be dictated
by any persistent symptoms and under the direction of the physician.

SECTION 5 - FIRE FIGHTING MEASURES

Flash Point: Not applicable.


Extinguishing Media: Use chemical foam, dry chemical, carbon dioxide or water.
Explosion Hazard: No applicable information has been found.
Fire Fighting Instructions: Contact emergency personnel. Use self-contained breathing
apparatus and full protective gear, if large quantities of product are involved. Hazardous
decomposition products may be released. Thermal degradation may produce oxides of
carbon and/or nitrogen; hydrocarbons and/or derivatives.

SECTION 6 - ACCIDENTAL RELEASE MEASURES

Procedures for Spill/Leak Clean-up:


For Household Settings: Absorb product and scrub the area with detergent. Dilute with water.
For Non-Household Settings: Use safety glasses or safety goggles if splash hazards exist; use
gloves and other protective clothing (apron, boots, etc) to prevent skin contact.

SECTION 7 - HANDLING AND STORAGE

Precautions for Safe Handling:


For Household Settings: Avoid contact with the eyes. Keep out of reach of children.
For Non-Household Settings: No unusual handling or storage requirements. Storage in large
quantities (as in warehouses) should be in a well-ventilated, cool area.
Conditions for Safe Storage:
For Household Settings: No applicable information has been found.
For Non-Household Settings: No unusual handling or storage requirements. Storage in large
quantities (as in warehouses) should be in a well-ventilated, cool area.
Other Recommendations: None.
SECTION 8 - EXPOSURE CONTROLS, PERSONAL PROTECTION

For Household Settings:


This is a personal care or cosmetic product that is safe for consumers and other users under
normal and reasonably foreseen use.
For Non-Household Settings:
Use safety glasses or safety goggles if splash hazards exist; use gloves and other protective
clothing (apron, boots, etc) to prevent skin contact. Always follow good hygienic work
practices. Avoid prolonged contact with skin and clothing.

SECTION 9 - PHYSICAL AND CHEMICAL PROPERTIES

Color, Odor and Appearance: Smooth


gel with characteristic odor.
Melting Point: Not applicable.
Physical State: gel . Boiling Point: >212F (>100C)
pH: 6.00-7.00 Solubility in Water: Slightly insoluble.
Flashpoint: Not applicable.
% VOC: Complies with Federal and State
regulations for VOC content.
Vapor Density: Not applicable. Specific Gravity: 0.98

SECTION 10 - STABILITY AND REACTIVITY

Conditions to Avoid: No applicable information has been found.


Other Recommendations: None.

SECTION 11 - TOXICOLOGICAL INFORMATION


This is a personal care or cosmetic product that is safe for consumers and other users under
intended and reasonably foreseeable use. Additional information on toxicological endpoints is
available from the supplier upon request.
Chronic Effects: Finished product is not expected to have chronic health effects.
Target Organs: No adverse health effects on target organs expected for finished product.
Carcinogenicity: Finished product is not expected to be carcinogenic.
NTP: No IARC: No OSHA: No

SECTION 12 - ECOLOGICAL INFORMATION

The product ingredients are expected to be safe for the environment at concentrations predicted
under normal use and accidental spill scenarios. Packaging components are compatible with the
conventional solid waste management practices. Additional information is available from the
supplier on request.
SECTION 13 - DISPOSAL CONSIDERATIONS

Disposal should be in accordance with Federal, State/Provincial and Local regulations.


For Household Settings: The following instructions are for consumer usage only. Do not
discharge product into natural waters without pre-treatment or adequate dilution.
For Non-Household Settings: Products covered by this MSDS, in their original form, when
disposed as waste, are considered non hazardous waste according to Federal RCRA regulations
(40 CFR 261). Disposal should be in accordance with local, state and federal regulations.

SECTION 14 - TRANSPORT INFORMATION

Finished packaged product transported by ground (DOT): Non hazardous


Finished packaged product transported by vessel (IMDG): Non hazardous
Finished packaged product transported by air (IATA): Non hazardous

SECTION 15 - ADDITIONAL REGULATORY INFORMATION

EU DPD (Dangerous Products Directive) Classification (DPD 88/379/EEC).


Regulated as a Cosmetic and/or Drug under FDA (US), HPB (Canada), Cosmetic Directive (EU),
MHW (Japan) and MOH (China).
While the finished product(s) is not considered hazardous as defined in 29 CFR 1910.1200 (d),
this MSDS contains valuable information critical to the safe handling and proper use of the product.

US Federal
The product described in this Material Safety Data Sheet is regulated under the Federal Food,
Drug, and Cosmetics Act and is safe to use as per directions on container, box or accompanying
literature (where applicable).

CERCLA reportable quantity (RQ): None.

Canada
All ingredients are CEPA approved for import to Canada. This product has been classified in
accordance with the hazard criteria of the Canadian Controlled Products Regulations (CPR) and
this MSDS contains all information required by the CPR.

US States
CA Prop 65:
This product is not subject to warning labeling under California Proposition 65.

Other
Perfumes contained within the products covered by this MSDS comply with appropriate IFRA
guidance.
SECTION 16 TEST OF EVALUATION OF THE IRRITATING
POWER OF A COSMETICS PRODUCT

Standard Method ICDRG


( International Contact Dermatitis Research Group )

EXECUTION OF THE TEST

The purpose of this test aims to demonstrate the cutaneous irritating power of a single
substance or of a finished cosmetic product. To such purpose this study is runned out on
25 voluntary subjects in good conditions of health, who dont suffer of cutaneous
illnesses and running symptoms of allergy. To each volunteer us requested a specific
document of authorization.
The substance to test is used pure or diluted in different concentrations in oil of Vaseline
if liposoluble or in water if water-soluble. Such value of dilution has to be always
mentioned with the obtained results.
The substance to test is applied on the skin through aluminium thin type chambers on a
part of skin located on the back. The chambers are fixed to the skin with adhesive
bandaid, paying attention that the skin must be integral and should not present scratches,
The period of application is fixed in 48 hours, the results (for the evaluation of the test)
are taken after 30 minutes, 24 hours and 48 hours.
The parameters taken in consideration to express a possible adverse answer are:
ERYTHEMA-EDEMA-SCALING-ITCH-BURNING. The degree of intensity of the
answer is expressed on the basis of: NEG, POS, +,++,

TEST RESULTS

VOLUNTEER READING 30 MIN. READING 24 NOWS READING 48 NOWS

1 NEGATIVE NEGATIVE NEGATIVE


2 NEGATIVE NEGATIVE NEGATIVE
3 NEGATIVE NEGATIVE NEGATIVE
4 NEGATIVE NEGATIVE NEGATIVE
5 NEGATIVE NEGATIVE NEGATIVE
6 NEGATIVE NEGATIVE NEGATIVE
7 NEGATIVE NEGATIVE NEGATIVE
8 NEGATIVE NEGATIVE NEGATIVE
9 NEGATIVE NEGATIVE NEGATIVE
10 NEGATIVE NEGATIVE NEGATIVE
11 NEGATIVE NEGATIVE NEGATIVE
12 NEGATIVE NEGATIVE NEGATIVE
13 NEGATIVE NEGATIVE NEGATIVE
14 NEGATIVE NEGATIVE NEGATIVE
15 NEGATIVE NEGATIVE NEGATIVE
16 NEGATIVE NEGATIVE NEGATIVE
17 NEGATIVE NEGATIVE NEGATIVE
18 NEGATIVE NEGATIVE NEGATIVE
19 NEGATIVE NEGATIVE NEGATIVE
20 NEGATIVE NEGATIVE NEGATIVE
21 NEGATIVE NEGATIVE NEGATIVE
SECTION 17 SAFETY DATA SHEET

1. IDENTIFICATION OF THE PRODUCT AND OF THE COMPANY.


1.1 COMMERCIAL NAME: Nexus Cream
1.2 TYPE OF PRODUCT AND USE: Skin care product.
1.3 PROVIDER COMPANY: PEER PHARM LTD AMAL 17st. AFEK
Industry Park Rosh-Ha Ayin 48092 Israel.

2. COMPOSITION INFORMATION ABOUT INGREDIENTS.


2.1 DANDEROUS SUBSTANCES CONTAINED: None

3. HAZARDS IDENTIFICATION.
3.1 DANGEROUS IN HEALTH AND PHYSIC INTEGRITY:
No specific dangers may be found in the normal use:

4. FIRST AID MEASURES.


4.1 EYE CONTACT: rinse very well at list fifteen minutes.
4.2 SKIN CONTACT: No precaution.
4.3 INHALATION: Breath in open fresh air. Draw medical attention if breathing is difficult.
4.4 INGESTION: Do not induce vomiting. Draw immediate medical attention.

5. FIRE FIGHTING MEASURES.


5.1 APPROPRIATE EXTINGUISHING MEDIA: CO2 Foams, Chemical powders.
5.2 INAPPROPRIATE EXTINGUISHING MEDIA: None
5.3 GENERAL HAZARD: Avoid breathing fumes
5.4 SPECIAL FIRE FIGHTING PROTECTVE EQUIPMENT: Use protection for respiratory ways

6. ACCIDENTAL COMING OUT MEASURES.


6.1 INDIVIDUAL PRECAUTION: Wear protective gloves
6.2 SORROUNDING PRECAUTION: Hold the losses with ground and sand.
Industrial grade vacuum sweepers are also recommended.
6.3 NETHODS OF CLEANING: Pick up the product to use it again if its possible.
For dry powder spills, inert materials such as sand may be added to control dusting prior
cleanup. After the harvest, wash with eater the place and the interested material.

7. HANDLING AND STORAGE.


7.1 HANDLING PRECATION: Do not smoking during works. Observe the hygiene in the
jobs place
7.2 STORAGE SHREWDNESS: Preserve the product in a fresh and good ventilate place
7.3 TECHNICAL DEVICES: Use gloves and protective glasses

8. EXPOSURE CONTROLS / PERSONAL PROTECTION.


8.1 EXPOSURE LIMITS: None in normal use
8.2 PERSONAL PROTECTION: Recommended safety glasses, powder mask, protective gloves.
9. PHYSICAL AND CHEMICAL PROPERTIES.
9.1 APPEAREANCE AND COLOUR: Fluid
9.2 ODOUR: Characteristic
9.3 MELTING POINT: fluid at 25C
9.4 WATER SOLUBILTY: Soluble
9.5 BOILING POINT: Superior 90C

10. STABILITY AND REACTIVITY.


10.1- CONDITION WHICH SHOULD BE AVOIDED: In normal condition the product is stable.

11. TOXICOLOGICAL INFORMATION.


11.1 - PENETRATION WAYS: Swallow, inhalation
11.2 - This product in general are considered to be practically non toxic
11.3 - ADDITIONAL INFORMATION: None

12. ECOLOGICAL INFORMATION.


12.1 - GENERAL: This product has not been evaluated for its ecotoxicity. However, the
biodegradation of inorganic colorants under aerobic conditions is expected to be
poor and there is no evidence to suggest they create any significant ecological problems
when released into the environment.

13. DISPOASL CONSIDERATION.


13.1 - GENERAL: Salvage if it is possible. This product must be disposed in accordance with
all applicable federal, state and local regulation.

14. TRANSPORT INFORMATION.


14.1 - GENERAL: This product is not subject to any regulation

15. CLASSIFICATION IN ACCORDING TO 67/548/EEC.


15.1 - GENERAL: The product is not dangerous

16. ADDITIONAL INFORMATION.


16.1 - THIS PRODUCT IS DERMATOLOGICAL TESTED

SECTION 18 - OTHER INFORMATION

DISCLAIMER: This MSDS is intended to provide a brief summary of our knowledge and
guidance regarding the use of this material. The information contained here has been compiled
from sources considered by Peer Pharm Ltd. to be dependable and is accurate to the best of the
Companys knowledge. It is not meant to be an all-inclusive document on worldwide hazard
communication regulations.
This information is offered in good faith. Each user of this material needs to evaluate the
conditions of use and design the appropriate protective mechanisms to prevent employee
exposures, property damage or release to the environment. Peer Pharm Ltd. assumed no
responsibility for injury to the recipient or third persons, or for any damage to any property
resulting from misuse of the product.

Mali Brikman
Manager of Quality Assurance,
Date: 7/03/2013
Peer Pharm Ltd.
CERTIFICAT OF FREE SALE
PEER PHARM LTD engaged in the manufacture of the following product:

NEXUS CREAM

Declares
That the cosmetic products above mentioned made in the respect of the CEE directive
and of the regulations concerning the production of cosmetics in Italy.

In particular she respects the following European community regulations:

Rapprochement of the legislations of the relative member states to the cosmetic products.
Dir. 76/768/CEE
Rapprochement of the legislations of the relative member states to the cosmetic products.
Common inventory and nomenclature of the used ingredients in the cosmetic products.
Dir. 96/335/CEE
Dir. 1223/2009/CE
and to the following Italian legislation:

Norms for the realization of the directive CEE on the production and sale of cosmetics.
L. 713 of the 11-10-1986:
DL 300 of the 10-09-1991
DL 126 of the 24-04-1997
DL 50 of the 15-02-2003
Relative measures for cosmetics, containing materials of animal origin and updating of the lists
attached to the L. 713.
DM 05-05-1996
DM 22-01-1999
Such products dont introduce any risk connected to BSE and are even made in accord with the
practices of good workmanship (ISO 22716 GMP) adopted in firm.
WE certified also that the products above listed are healthy and sure and they are freely and
largely sold in Italy and in all over countries of the European Community.

PEER PHARM LTD

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