HAND SANITIZER- alcohol gel 
FARMACIA SAN ARCANGEL, S.A DE C.V

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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Active Ingredients

Ethyl alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only . flammable - keep away from heat or flame

Do not use

In children less than 2 months of age - on open skin wounds

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throrugly with water

Stop use and ask a doctor

if irritation or rash occurs. These maybe 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

Put enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

Other information

Store between 15-30C (58-86F)

Avoid freezing and excesive heat above 40C (104F)

Inactive ingredients

Water (aqua), Vegetable Glycerine UPC, Hudroxypropyl methylcellulose and carboxymethylcellulose.

Principal Display

Hand sanitizer

70% alcohol

68 fl. oz. (2.1qt) (2L) label 2000 ml

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80535-0002-12000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/23/2020
Labeler - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
Registrant - FARMACIA SAN ARCANGEL, S.A DE C.V (951583068)
Establishment
NameAddressID/FEIBusiness Operations
FARMACIA SAN ARCANGEL S.A DE C.V951583068manufacture(80535-0002) , label(80535-0002) , pack(80535-0002)

Revised: 9/2020
Document Id: b000150f-3bec-2e6c-e053-2995a90a67d5
Set id: b000150f-3beb-2e6c-e053-2995a90a67d5
Version: 1
Effective Time: 20200923
 
FARMACIA SAN ARCANGEL, S.A DE C.V