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Name:Betadineskin Cleanser
Manufacturer:Purdue Products Lp
Category:Over-the-counter (OTC) Marketed Drugs


Betadine Skin CleanserPovidone-iodine, 7.5%

BETADINE SKIN CLEANSER - povidone-iodine solution 
Purdue Products LP

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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Betadine Skin Cleanser

Povidone-iodine, 7.5%

Drug Facts

Active ingredient

Povidone-iodine, 7.5% – equal to 0.75% available iodine

Purpose

Antiseptic

 
Uses
  • disinfectant hand wash and skin cleanser
  • significantly reduces bacteria on the skin

Warnings

For external use only

Do not use this product

  • if you are sensitive to iodine or other product ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • serious burns
  • animal bites

Stop using this product and ask a doctor if

  • redness, irritation, swelling, or pain continues or increases
  • infection occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet skin and apply a sufficient amount for lather to cover all surfaces
  • wash vigorously for at least 15 seconds
  • rinse and dry thoroughly

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, sodium hydroxide

©2004, 2007, Purdue Products L.P.

Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431

L01062A 301011-0B

Betadine Skin Cleanser
NDC 67618-149-04

Betadine Skin Cleanser

BETADINE  SKIN CLEANSER
povidone-iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-149
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE .075 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM NONOXYNOL-4 SULFATE  
NONOXYNOL-9  
WATER  
SODIUM HYDROXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67618-149-04 118 mL in 1 BOTTLE, DISPENSING None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/15/1973

Labeler - Purdue Products LP (141916531)
Establishment
Name Address ID/FEI Operations
Thatcher Company 041307356 MANUFACTURE

Revised: 01/2011 Purdue Products LP



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


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