HAND SANITIZER- alcohol gel
Pafer Foods & Beverages, S. de R.L 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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Ethyl alcohol 70% v/v

Antiseptic

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

For external use only

Flammable. Keep away from heat or flame

Do not use:

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

Keep out of reach of children.

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

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.

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

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

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

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78319-007
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78319-007-01	5000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

Name	Address	ID/FEI	Business Operations
Establishment
Pafer Foods & Beverages, S. de R.L. de C.V.		812764102	pack(78319-007) , label(78319-007)