HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pafer Foods & Beverages, S. de R.L de C.V., Pafer Foods & Beverages, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethyl alcohol 70% w/w

PURPOSE

Antiseptic

INDICATIONS & USAGE

• Hand Sanitizer to help reduce bacteria on the skin
• For use when soap and water are not available
• Recommended for repeated use

WARNINGS

For external use only

Flammable. Keep away from heat or flame

DO NOT USE

Do not use:

• In children less than 2 months of age
• On open skin wounds

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, get medical help or contact poison control center right away.

DOSAGE & ADMINISTRATION

Directions:

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years in the use of this product.

OTHER SAFETY INFORMATION

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

Aminoethyl Propanol, Acrylates Copolymer, Glycerin, Hydrogen Peroxide, Purified Water, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78319-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
GLYCERIN (UNII: PDC6A3C0OX)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78319-009-01	370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Pafer Foods & Beverages, S. de R.L de C.V. (812764102)

Registrant - Pafer Foods & Beverages, S. de R.L de C.V. (812764102)

Establishment
Name	Address	ID/FEI	Business Operations
Pafer Foods & Beverages, S. de R.L. de C.V.		812764102	pack(78319-009) , label(78319-009)