ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER - alcohol spray
National Pen Co., LLC

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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ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER

Label

ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER

USE: To decrease germs on the skin if water is not available. DIRECTIONS: Spray directly on skin.

Active Ingredient: Ethyl Alcohol (62%) Inactive Ingredients: Purified Water, Glycerin, Aloe Vera Scent.

WARNINGS: For external use only. Do not use in or near the eyes. Keep out of the reach of children.

FLAMMABLE: Keep away from open flame. Size: 8ml/.25oz.

Contents made in USA. Packaging made in China. Distributed by National Pen Co., San Diego, 1-800-854-1000 * www.pens.com

Image of Hand Sanitizer Label

Active Ingredient:

Ethyl Alcohol (62%)

Inactive Ingredients:

Purified Water, Glycerin, Aloe Vera Scent

USE:

To decrease germs on the skin if water is not available.

DIRECTIONS:

Spray directly on skin.

Child Warning:

Keep out of the reach of children.

WARNINGS:

For external use only. Do not use in or near the eyes.

FLAMMABLE: Keep away from open flame.

Size:

8ml/.25oz.

ANTIBACTERIAL HAND SANITIZER POCKET SPRAYER
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51087-272
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	4.96 mL in 8 mL

Ingredient Name	Strength
Inactive Ingredients
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51087-272-08	8 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/03/2011

Labeler - National Pen Co., LLC (809293140)

Registrant - National Pen Co., LLC - San Diego, CA (807081638)

Name	Address	ID/FEI	Business Operations
Establishment
National Pen Co., LLC		809293140	pack, label

Name	Address	ID/FEI	Business Operations
Establishment
National Design LLC		360763320	relabel

Name	Address	ID/FEI	Business Operations
Establishment
Atlas Pen & Pencil Corp		876616025	relabel

Name	Address	ID/FEI	Business Operations
Establishment
Crown Laboratories		079035945	manufacture