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Name:Alcohol Prep
Manufacturer:Major Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


Alcohol Prep Pads

ALCOHOL PREP   - isopropyl alcohol swab 
Major Pharmaceuticals

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 Prep Pads

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic


Use:alcohol prep pads

Antiseptic cleanser for preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire

Indications and Usage:


  • Topical cleansing and preparation of skin prior to  injection.

Keep out of reach of children.

  • 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 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

Inactive Ingredient

  • Water

Do Not Use

  • With electrocautery procedures
  • in the eyes

Stop use and ask a doctor if:

  • irritation and redness develops
  • if condition persists for more than 72 hours, consult a physician.

Principal Display Panel

Alcohol Prep Pad

Major_Alcohol_Prep_Pads



ALCOHOL PREP  
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-6245
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 1.4 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:0904-6245-60 10 BOX ( BOX) in 1 CASE contains a BOX
1 100 SWAB ( SWAB) in 1 BOX This package is contained within the CASE (0904-6245-60)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/21/2011

Labeler - Major Pharmaceuticals (191427277)

Revised: 05/2011 Major Pharmaceuticals



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


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