HAND SANITIZER- alcohol gel 
EXPORTADORA IN & OUT S DE SR DE CV

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.

----------

Active ingredient

Ethyl alcohol v/v 70%

purposes

antimicrobial

uses

hand sanitizer to decrease virus and bacteria on the skin that could cause disease

recommended for repeated 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 the 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 the 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 persist for more than 72 hours

keep out of reach of children

if swallowed, get medical help or contact 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 under 6 years of age shoul be supervised when using

not recommended for infants

other information

store below 105 F (40C)

may discolor certain fabrics

harmful to wood finishes and plastics

inactive ingredients

purified water (aqua), vegetable glycerin and carboxymethyl cellulose

principal display

label 250 ml hand sanitizer

desinfectante de manos

kills 99.9% de la mayoria de germenes

70% alcohol volume

non sterile solution

8.5 fl oz (250 ml)

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77210-0009
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) 21.8 mL  in 100 mL
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 3.2 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77210-0009-1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/13/2020
Labeler - EXPORTADORA IN & OUT S DE SR DE CV (951577298)

Revised: 6/2020
Document Id: a7fcfffa-9b71-15b9-e053-2995a90ac4d3
Set id: a7fcfffa-9b70-15b9-e053-2995a90ac4d3
Version: 1
Effective Time: 20200613
 
EXPORTADORA IN & OUT S DE SR DE CV