ANTIMICROBIAL HAND SANITIZER- alcohol rub gel
Hanover Pen Corp dba HPC Global

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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Antimicrobial Hand Sanitizer Gel

alcohol gel

Active Ingredient

Ehtyl Alcohol 70%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on skin.
Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use in the eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

Keep out of reach of children.

If ingested get medical help or contact a Poison Control Center right away.

Directions

wet hands thoroughly with product allow to dry without wiping.
children under six should be supervised while using this product.

Inactive Ingredients

aloe vera, carbomer, purified water, triethanolamine

Pkgd by HPC Global, Hanover PA, 17331

Made in USA 0.50 fl. oz. Lot# ****

Drug Facts

ANTIMICROBIAL HAND SANITIZER
alcohol rub gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51811-415
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	10.353 mL in 14.79 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51811-415-40	14.79 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/13/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/13/2010

Labeler - Hanover Pen Corp dba HPC Global (003022670)

Registrant - Robert Houghland (003022670)

Name	Address	ID/FEI	Business Operations
Establishment
Hanover Pen Corp dba HPC Global		003022670	relabel(51811-415) , repack(51811-415)