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Name:Alcohol Prep Pad
Manufacturer:Dukal Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALCOHOL PREP PAD  - isopropyl alcohol swab 
Dukal Corporation

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

Active Ingredients

Isopropyl Alcohol 70%

Purpose

Antiseptic Cleanser

Use

For Preparation of Skin prior to an injection

Warnings

  • For External Use Only
  • Flammable, Keep away from fire or flame

Do Not Use

  • with electrocautery procedures
  • In the Eyes. If contact occurs, flush eyes with water

Stop Use

If irritation and redness develop. If condition persists, consult your health care practitioner.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wipe injection site vigorously and discard.

Other Information

Store at Room Temperature 15 - 30 C (59 - 86 F)


Inactive Ingredient

purified water

Alcohol Prep Pad

1 Medium Pad

Dist. By:

Total Resources Int'l

Walnut, CA 91789

Made in China

NDC 65517-0015-1

REORDER NO: 00-ALC-90730

Prep Pad Label


ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65517-0015
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.70 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65517-0015-1 0.4 mL in 1 POUCH None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333 06/01/2010

Labeler - Dukal Corporation (791014871)

Revised: 06/2010 Dukal Corporation



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


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