Hand Sanitizer by Pafer Foods & Beverages, S. de R.L de C.V. / Pafer Foods & Beverages, S. de R.L. de C.V. Citrus

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]

HAND SANITIZER- alcohol liquid 
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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Citrus

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 liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78319-004
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)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78319-004-01	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	07/03/2020

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(78319-004) , label(78319-004)

Revised: 7/2020

Document Id: ab25b145-aedf-cc77-e053-2a95a90a2a7d

34390-5

Set id: a969c734-27b5-531a-e053-2a95a90a8858

Version: 3

Effective Time: 20200723

 

Pafer