Betadine skin cleanser solution

Otc - active ingredient section

Drug Facts

Active ingredient

Povidone-iodine, 7.5% equal to 0.75% availableiodine

Otc - purpose section

Purpose

First aid antiseptic

Indications & usage section

Uses

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

Indications & usage section

Warnings
For external use only

    Do not use this product
  • in the eyes
  • over large areas of the body
  • If you are allergic to povidone-iodine or any other ingredientsin this preparation
  • Longer than 1 week unless directed by a doctor

Otc - do not use section

    Ask a doctor before use if you have
  • deep or puncture wounds
  • serious burns
  • animal bites

Otc - stop use section

    Stop using this product and ask a doctor if
  • redness, irritation, swelling, or pain continues or increases
  • infection occurs

Otc - keep out of reach of children section

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

Otc - when using section

Directions

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

How supplied section

Other information

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

Inactive ingredient section

Inactiveingredients

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

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

301011-0F

©2015, Purdue Products L.P.


Dosage forms & strengths section

Dosage & administration section

Warnings section

Ingredients and appearance - Product information

Betadine skin cleanser solution- Povidone-iodine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 67618-149
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Povidone-iodine ( UNII: 85H0HZU99M)( Iodine - UNII: 9679TC07X4 ) 7.5 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Ammonium nonoxynol-4 sulfate ( UNII: 9HIA70O4J0)
Nonoxynol-9 ( UNII: 48Q180SH9T)
Water ( UNII: 059QF0KO0R)
Sodium hydroxide ( UNII: 55X04QC32I)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part333A USA

Labeler - Purdue Products LP( 141916531)

Establishment

Name ID/FEI Business Operations
Purdue Products LP 141916531 MANUFACTURE( 67618-149)

Package label.principal display panel

BetadineSkin Cleanser
NDC: 67618-149-04