HAND SANITIZER - alcohol 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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Active Ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

For handwashing to decrease bacteria on skin without soap and water.

Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use

Do not use in the eyes. If this happens rinse throughly with water

Stop use and ask a doctor

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 throughly with product

allow to dry without wiping

children under six should be supervised while using this produce.

Inactive Ingredients

aloe vera, carbomer, fragrance, purified water, triethanolamine

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Front Label

NDC 51811-376-26

Hand Sanitizer - Fresh

16 FL OZ (473ML)

Back Label (Drug Facts)

Hand Sanitizer - Citrus

HPC Global, Hanover PA, 17331

Made in USA

Image Drug Facts Label

HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51811-376
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (Alcohol)	Alcohol	.665 g in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Trolamine
Aloe
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:51811-376-26	237 mL in 1 BOTTLE, PUMP	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	02/01/2012

Labeler - Hanover Pen Corp dba HPC Global (003022670)

Registrant - Hanover PEn Corp dba HPC Global (003022670)

Establishment
Name	Address	ID/FEI	Operations
Hanover Pen Corp dba HPC Global		003022670	repack, label

Establishment
Name	Address	ID/FEI	Operations
Safetec of America, Inc.		874965262	manufacture

Revised: 02/2012 Hanover Pen Corp dba HPC Global