APLICARE ANTISEPTIC HAND RINSE  - alcohol gel 
Aplicare, 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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Alcohol Denat. (anhydrous) 62%

Antiseptic


For external use only.  Keep out of eyes.  If contact with eyes occurs, rinse promptly and thoroughly with water.

Flammable.  Keep away from fire or flame.

Stop use and ask a doctor if significant irritation or sensitization occurs.

Keep out of reach of children.  In case of accidental
ingestion, seek professional assistance
or consult a poison control center immediately.

Questions or comments?

1-800-760-3236 (Mon to Fri 8:30 AM - 5:00 PM EST)

acrylates/C10-30 alkyl acrylate crosspolymer

diisopropanolamine

FDandC blue no. 1

FDandC yellow no. 5

fragrance

PPG-20 methyl glucose ether

water

Use

instant hand antiseptic

Directions

Antiseptic Gel Hand Rinse 4 oz.

Antiseptic Gel Hand Rinse 4 oz.


APLICARE ANTISEPTIC HAND RINSE 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1614
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (Alcohol) Alcohol62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Diisopropanolamine 
FD&C Blue No. 1 
FD&C Yellow No. 5 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:52380-1614-260 mL in 1 BOTTLENone
2NDC:52380-1614-4120 mL in 1 BOTTLENone
3NDC:52380-1614-6480 mL in 1 BOTTLENone
4NDC:52380-1614-01.5 mL in 1 PACKETNone
5NDC:52380-1614-3360 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/01/1998

Labeler - Aplicare, Inc. (107255002)
Establishment
NameAddressID/FEIOperations
Aplicare, Inc.058377631manufacture

Revised: 09/2011 Aplicare, Inc.