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Name:Alcohol Prep Pad
Manufacturer:B��ttner-frank Gmbh
Category:Over-the-counter (OTC) Marketed Drugs


ALCOHOL PREP PAD  - isopropyl alcohol swab 
Büttner-Frank GmbH

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

Isopropyl Alcohol 70% v/v

Inactive Ingredient

Purified Water

Purpose

Antiseptic

Use

For Preparation of skin prior to injection

Keep Out of Reach of Children

Keep out of reach of children

Directions

Wipe Injection site vigorously and discard

Warnings

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

Do not use

  • With electrocautary procedures
  • In the eyes.  
Stop use if irritation or redness develop.  If the condition persists for more than 72 hours consult a doctor.
If swallowed, get medical help or contact a Poison Control Center right away.

Package Label

Latex Free Alcohol Prep Pad  Antiseptic

Buttner-Frank GmbH  Am Wolfsmantel 9-11  91058 Erlangen, Germany

Contents: 1 Pad  LOT_____________ EXP _________________  NDC _____________________

Tear Here

Swab Label


ALCOHOL PREP PAD 
isopropyl alcohol swab
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36769-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL .70 mg  in 1 mg
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:36769-001-10 800 PACKET ( PACKET) in 1 BOX contains a PACKET (36769-001-01)
1 NDC:36769-001-01 300 mg in 1 PACKET This package is contained within the BOX (36769-001-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 02/04/2011

Labeler - Büttner-Frank GmbH (318446978)
Registrant - Büttner-Frank GmbH (318446978)
Establishment
Name Address ID/FEI Operations
Büttner-Frank GmbH 318446978 manufacture, label

Revised: 02/2011 Büttner-Frank GmbH



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


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