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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Drug Facts

Active Ingredient

Ethyl Alcohol 66.5 percent

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

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

Stop use and ask a doctor

Stop use and ask a doctor if irritation of redness develops 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 product.

Inactive Ingredients

aloe vera, carbomer, D and C number 5, D and C yellow number 10, fragrance, purified water, triethanolamine

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Front Label

NDC 51811-376-16

Hand Sanitizer - Fresh

16 FL OZ (473ML)

Back Label (Drug Facts)

Hand Sanitizer - Fresh

Distributed by

HPC Global, Hanover PA, 17331

Made in USA


Image Drug Facts Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-376
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.665 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Trolamine (UNII: 9O3K93S3TK)  
Aloe (UNII: V5VD430YW9)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51811-376-16473 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2012
Labeler - Hanover Pen Corp dba HPC Global (003022670)
Registrant - Hanover Pen Corp dba HPC Global (003022670)
Establishment
NameAddressID/FEIBusiness Operations
Hanover Pen Corp dba HPC Global003022670repack, label
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262manufacture

Revised: 2/2012
Document Id: 5cd2190d-dccf-4c5d-9a91-5b221e9a6724
Set id: 2b3f98a5-2cab-4316-8c59-0ea047da2f43
Version: 1
Effective Time: 20120201
 
Hanover Pen Corp dba HPC Global