MEDICHOICE HAND SANITIZER - alcohol gel 
Donovan Industries, Inc.

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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MediChoice Alcohol Gel Hand Sanitizer

Drug Facts

 Active Ingredients:                                      Purpose

Ethyl Alcohol 62 percent                             Antiseptic

Use: For handwashing to decrease bacteria on skin.

Warnings:

Flammable. Keep away from heat or flame.

For external use only.

Do not use in the eyes.

In case of deep or puncture wounds, consult doctor.

In rare instances of irritation, discontinue use if irritation and redness  develop.

If condition persists for more than 72 hours, consult a physician.

If swallowed, contact a physician or poison center.

Keep out of reach of children.


Directions:

To decrease bacteria on skin, apply a small amount to palm.

Briskly rub covering hands with product until dry.

Inactive Ingredients: Water, Isopropyl Alcohol, Hydrogenated Starch, Carbomer, THP Ethylenediamine, and Fragrance.

MediChoice

Alcohol Gel

Hand Sanitizer


4 FL. OZ. 118ml


MediChoiceHandSanitizer

MEDICHOICE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-4000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
ETHYLENEDIAMINE (UNII: 60V9STC53F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55504-4000-1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33312/31/2009
Labeler - Donovan Industries, Inc. (096662267)
Establishment
NameAddressID/FEIBusiness Operations
Chester Packaging, LLC. Inc.004237806manufacture

Revised: 12/2009
Document Id: f901a748-4ab5-4aee-a87c-baf5b6f8c219
Set id: c6412428-7b67-4337-950f-008e441eae1d
Version: 4
Effective Time: 20091210
 
Donovan Industries, Inc.