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Name:Amp Instant Hand Sanitizer
Manufacturer:Whisk Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


AMP INSTANT HAND SANITIZER  - alcohol soap 
Whisk Products, 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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Active Ingredient
Ethyl Alcohol 60% v/v

Purpose
Skin Sanitizer

Use
To help reduce amount of bacteria on the skin

Warnings
Flammable.  Keep away from fire or flame.
For external use only.  If swallowed, seek medical attention.
When using this product do not use around or near the eyes.  If contact occurs, flush eyes with water and contact doctor immediately.
Stop use and consult a doctor when skin irritation appears and lasts.
Keep out of reach of children.

Directions
  • Place 5 grams or palmful of product in one hand.
  • Spread on hands and rub into skin until dry.
  • Place a smaller amount (2.5 grams) in one hand and spread over both hands and wrists.
  • Rub into skin until dry.
  • Children should be supervised while using this product.

Inactive Ingredients
Water, Glycerin, Fragrance, Carbomer, Propylene Glycol, Diisopropylamine

Label for 12 fl. oz. bottle

AMP INSTANT HAND SANITIZER 
hand sanitizer soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-503
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (Alcohol) Alcohol 600 mL  in 1 L
Inactive Ingredients
Ingredient Name Strength
Water  
Glycerin  
Propylene Glycol  
Diisopropylamine  
Carbomer Interpolymer Type A (55000 CP)  
Product Characteristics
Color white (water white - colorless, crystal clear) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65585-503-01 0.355 L in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 12/09/2009

Labeler - Whisk Products, Inc. (834270639)
Establishment
Name Address ID/FEI Operations
Whisk Products, Inc. 834270639 repack

Revised: 12/2009 Whisk Products, Inc.



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


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