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

Uses

Uses

* Helps eliminate bacterias 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

Active Ingredient

Active Ingredient Purpose

Warnings

Stop use and ask a doctor if

Stop use and ask a doctor if

* Irritation develops

Keep out of reach of children

Keep out of reach of children. In case of incidental ingestion, see professional advice or contact a Poison Control Center inmediately.

Directions

Directions:

Inactive Ingredients

Water, citric acid, glycerine, propylene glycol

Questions?

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

Uses

Uses

* 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

Hand Sanitize

Label

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79894-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79894-002-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/29/2020
Labeler - SAMARA COSMETICS S.A.S. (881793172)
Registrant - SAMARA COSMETICS S.A.S. (881793172)
Establishment
NameAddressID/FEIBusiness Operations
SAMARA COSMETICS S.A.S.881793172manufacture(79894-002)

Revised: 7/2020
Document Id: aba5c61f-71e5-c885-e053-2a95a90ae54c
Set id: aba5f862-1461-52ac-e053-2a95a90af2de
Version: 1
Effective Time: 20200729
 
SAMARA COSMETICS S.A.S.