Aplicare Antiseptic Gel Hand Rinse

Generic Name: alcohol gel
Dosage Form: gel

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.

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 4 oz

Aplicare Antiseptic Gel Hand Rinse 
antiseptic gel hand rinse gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52380-1614
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 62 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water  
Diisopropanolamine  
FD&C Blue No. 1  
FD&C Yellow No. 5  
Packaging
# Item Code Package Description
1 NDC:52380-1614-2 60 mL in 1 BOTTLE
2 NDC:52380-1614-4 120 mL in 1 BOTTLE
3 NDC:52380-1614-6 480 mL in 1 BOTTLE
4 NDC:52380-1614-0 1.5 mL in 1 PACKET
5 NDC:52380-1614-3 360 mL in 1 BOTTLE
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. 058377631 manufacture
Revised: 04/2010
 
Aplicare, Inc.



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