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

First aid antiseptic

Uses

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

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 ingredients in this preparation
  • 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

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

301011-0F

©2015, Purdue Products L.P.


Betadine Skin Cleanser
NDC: 67618-149-04

Betadine Skin Cleanser
BETADINE SKIN CLEANSER 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-149
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-149-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/198007/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/198007/01/2021
Labeler - Purdue Products LP (141916531)
Registrant - Purdue Pharma LP (932323652)
Establishment
NameAddressID/FEIBusiness Operations
Thatcher Company041307356MANUFACTURE(67618-149)

Revised: 1/2016
Document Id: d5b564e0-5f0e-b880-65e5-5dfd746f1332
Set id: 5a71a971-4397-4bde-b14f-47adc2785ca2
Version: 3
Effective Time: 20160127
 
Purdue Products LP