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Name:Aplicare Antiseptic Hand Rinse
Manufacturer:Aplicare, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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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Drug Facts

Alcohol Denat. (anhydrous) 62%

Antiseptic


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

Aplicare Antiseptic Gel Hand Rinse Packet

Antiseptic Gel Hand Rinse Packet


APLICARE ANTISEPTIC HAND RINSE 
ethanol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0540
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 62   in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Diisopropanolamine  
FD&C Blue No. 1  
FD&C Yellow No. 5  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52380-0540-1 1.5 mL in 1 PACKET None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 08/01/2006

Labeler - Aplicare, Inc. (107255002)
Establishment
Name Address ID/FEI Operations
Aplicare, Inc. 107255002 repack
Establishment
Name Address ID/FEI Operations
Aplicare, Inc. 058377631 manufacture

Revised: 04/2010 Aplicare, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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