HAND SANITIZER- alcohol gel 
Ignacio Reyes González

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 250 mL

DIRECTIONS OF DOSAGE AND ADMINISTRATION

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.

INACTIVE INGREDIENTS

Water, Glycerin, Carbomer, Triethanolamine

INDICATIONS AND USAGE

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.

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.

ANTIMICROBIAL

Antimicrobial

WARNINGS

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.

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%

HAND SANITIZER GEL PRINCIPAL DISPLAY LABEL

LABEL 250 mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77196-003
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:77196-003-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/22/2020
Labeler - Ignacio Reyes González (951577216)
Registrant - Ignacio Reyes González (951577216)
Establishment
NameAddressID/FEIBusiness Operations
Ignacio Reyes González951577216manufacture(77196-003)

Revised: 5/2020
Document Id: a6375d4c-39f8-f091-e053-2a95a90a75a0
Set id: a6375d4c-39f7-f091-e053-2a95a90a75a0
Version: 1
Effective Time: 20200522
 
Ignacio Reyes González