ALCOHOL PREP PAD - isopropyl alcohol swab 
Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:36769-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.70 mg  in 1 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36769-001-01300 mg in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/04/2011
Labeler - Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel (318446978)
Registrant - Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel (318446978)
Establishment
NameAddressID/FEIBusiness Operations
Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel318446978manufacture(36769-001) , label(36769-001) , pack(36769-001)

Revised: 1/2013
Document Id: f7fb4376-49a4-441e-aca6-dd5942b0b37c
Set id: bcb4c25b-7d77-4b95-acc1-b10a0e68b4ef
Version: 2
Effective Time: 20130114
 
Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel