HAND SANITIZER- alcohol gel 
GUTIERREZ RAZO Y ASOCIADOS, 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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INACTIVE INGREDIENTS

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.

Use[s]

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

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

Purpose. Antmicrobial

Warnings

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

Children under 6 years of age should be supervised when using.

STOP USE

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

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

WARNINGS

Warnings

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

Other information

Store below 110°F (43°C)

DOSAGE AND ADMINISTRATION

Use[s]

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

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

PACKAGE LABEL

LABEL 250 mL english JPG2LABEL 500 mL jpg englishLABEL 1000 mL JPG englishLABEL 4000 mL FINAL jpg

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78770-3000
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
TRIETHANOLAMINE CAPROYL GLUTAMATE (UNII: 0F2FO57253) 0.002 mL  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.0375 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78770-3000-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
2NDC:78770-3000-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
3NDC:78770-3000-51000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
4NDC:78770-3000-64000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/2020
Labeler - GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V. (951578901)
Registrant - GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V. (951578901)
Establishment
NameAddressID/FEIBusiness Operations
GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V.951578901manufacture(78770-3000)

Revised: 6/2020
Document Id: a74f5b04-841e-8b5c-e053-2a95a90abcf2
Set id: a74f5b04-841d-8b5c-e053-2a95a90abcf2
Version: 1
Effective Time: 20200605
 
GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V.