HAND SANITIZER- alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Ignacio Reyes González. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77196-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77196-003-01	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/22/2020

Labeler - Ignacio Reyes González (951577216)

Registrant - Ignacio Reyes González (951577216)

Establishment
Name	Address	ID/FEI	Business Operations
Ignacio Reyes González		951577216	manufacture(77196-003)