HAND SANITIZER- alcohol gel 
COMERCIAL GOURA,S. DE R.L.

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

DIRECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

Directions

Place 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.

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE SECTION

Purpose

Antmicrobial

WARNINGS AND PRECAUTIONS

Warnings

For external use only. Flammable. Keep away from heat or flame

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

Store below 110°F (43°C)

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

ASK A DOCTOR

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

ASK A DOCTOR

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

STOP USE

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

WARNING

Warnings

For external use only. Flammable. Keep away from heat or flame

PACKAGE LABELS

LABEL 250 mL english JPG2LABEL 500 mL AMDAYLABEL 1000 mL JPG english LABEL 4000 mL FINAL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78501-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78501-1000-4250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
2NDC:78501-1000-5500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
3NDC:78501-1000-61000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
4NDC:78501-1000-74000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/26/2020
Labeler - COMERCIAL GOURA,S. DE R.L. (951578628)
Registrant - COMERCIAL GOURA,S. DE R.L. (951578628)
Establishment
NameAddressID/FEIBusiness Operations
COMERCIAL GOURA,S. DE R.L.951578628manufacture(78501-1000)

Revised: 7/2020
Document Id: aa598b34-5486-d28a-e053-2a95a90ad5fd
Set id: a69ab8dc-1009-7639-e053-2995a90aadb7
Version: 3
Effective Time: 20200713
 
COMERCIAL GOURA,S. DE R.L.