HAND SANITIZER- alcohol liquid 
SAMARA COSMETICS S.A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HAND SANITIZER LIQUID

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 68% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

* Helps eliminate bacteria on the hand and parts of the body that needs to be cleaned. This product is not a substitute of soap hand washing. Avoid contact with broken or damaged skin

Warnings

Do not use

Stop use and ask a doctor if

* Irritation develops

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

QUESTIONS OR COMMENTS: (574) 4448438 Ext 108 (Monday to Friday) 6:30 am to 4:30 pm (UTC/GMT 5 hours)

Inactive ingredients

glycerin, water. citric acid, propanediol

Package Label - Principal Display Panel

Label

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79894-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.05 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.45 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79894-001-0133.75 mL in 1 BOTTLE; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - SAMARA COSMETICS S.A.S. (881793172)
Registrant - SAMARA COSMETICS S.A.S. (881793172)
Establishment
NameAddressID/FEIBusiness Operations
SAMARA COSMETICS S.A.S.881793172manufacture(79894-001)

Revised: 7/2020
Document Id: abbd97e4-8be7-4ff2-e053-2a95a90ae33d
Set id: abbdc612-ca8d-f6a9-e053-2a95a90a6dea
Version: 1
Effective Time: 20200731
 
SAMARA COSMETICS S.A.S.