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 Ingredient

Alcohol v/v 70%

Purposes

Antimicrobial

Uses

Hand sanitizer to decrease bacteria on the skin that could cause disease

Recommended for repetead use

Warnings

for external use only: hands

flammable, keep away from fire and flame

When using this product

keep out of eyes, do not use in or near eyes.

-in case of contact with eyes flush thorougly with water

-avoid contact with broken skin

-do not inhale or ingest

when using this product

keep out of eyes, do not use in or near eyes.

-in case of contact with eyes flush thorougly with water

-avoid contact with broken skin

-do not inhale or ingest

Stop use and ask a doctor if

Irritation and redness develop

Condition persists for more than 72 hours

keep out of reach of children

if swallowed get medical help or contact a poison control center right away

Directions

put enough product in your palm to cover hands and rub hands together briskly until dry without wiping

for children uncer 6 years of age should be supervised when using

not recommended for infants

Other information

Store below 105 F (40 c)

may discolour certain fabrics

harmful to wood finishes and plastics

Inactive Ingredients

Purified water (aqua), Vegetable glycerin, Hydroxipropyl methylcellulose, carboxymethyl cellulose

Principal Display

label 20 L Hand sanitizer gel

eliminates 99.9% of germs

70% alcohol

Natural ingredients hands soft

Contains moisturizers

640 fl oz/ 20 L

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80535-0004
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)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
HYPROMELLOSE 2208 (60000 MPA.S) (UNII: 2F7T07H9ZD)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80535-0004-120000 mL in 1 DRUM; Type 0: Not a Combination Product10/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/29/2020
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.V951583068label(80535-0004) , manufacture(80535-0004) , pack(80535-0004)

Revised: 10/2020
Document Id: b2d495df-a370-b247-e053-2995a90a7baa
Set id: b2d495df-a36f-b247-e053-2995a90a7baa
Version: 1
Effective Time: 20201029
 
FARMACIA SAN ARCANGEL, S.A DE C.V