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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HAND SANITIZER GEL DEFENSE

DOSAGE AND ADMINISTRATION

Directions

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

INACTIVE INGREDIENTS

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

USES

Use[s]

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

KEEP AWAY FROM CHILDREN

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

PURPOSE

Purpose Antmicrobial

WARNINGS AND PRECAUTIONS

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

WARNINGS

Warnings

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

ACTIVE INGREDIENT

Active ingredient. Ethyl Alcohol 70% v/v

ASK A DOCTO

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.

PACKAGE LABEL

LABEL 250 ml GEL DEFENSE

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78770-4000
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
CARBOMER 940 (UNII: 4Q93RCW27E) 0.002 mL  in 1 mL
WATER (UNII: 059QF0KO0R) 0.2585 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78770-4000-7250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/17/2020
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(78770-4000)

Revised: 6/2020
Document Id: a8430e43-047f-1179-e053-2995a90a7e1d
Set id: a8430e43-047e-1179-e053-2995a90a7e1d
Version: 1
Effective Time: 20200617
 
GUTIERREZ RAZO Y ASOCIADOS, S.A. DE C.V.