BETADINE- 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 Solution

10% Povidone-iodine

Drug Facts

Active ingredient

Povidone-iodine, 10% (1% available iodine)

Purpose

Antiseptic

Uses

  • for preparation of the skin prior to surgery
  • helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Do not use

  • in the eyes
  • if you are allergic to povidone-iodine or any other ingredients in this preparation

When using this product

  • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
  • in pre-operative prepping, avoid “pooling” beneath the patient

Stop use and ask a doctor if

  • irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

purified water, sodium hydroxide

©2008, Purdue Products L.P.

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

L01060B       301010-0C

Betadine Solution
NDC 67618-150-16

Betadine Solution NDC 67618-150-16
BETADINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67618-150
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE.01 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM NONOXYNOL-4 SULFATE 
NONOXYNOL-9 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67618-150-0514.8 mL in 1 BOTTLE
2NDC:67618-150-04118 mL in 1 BOTTLE
3NDC:67618-150-08237 mL in 1 BOTTLE
4NDC:67618-150-09237 mL in 1 BOTTLE
5NDC:67618-150-16473 mL in 1 BOTTLE
6NDC:67618-150-17473 mL in 1 BOTTLE
7NDC:67618-150-32946 mL in 1 BOTTLE
8NDC:67618-150-013780 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/1996
Labeler - Purdue Products LP (141916531)
Establishment
NameAddressID/FEIBusiness Operations
Thatcher Company041307356MANUFACTURE

Revised: 2/2011
Document Id: 41891599-420e-48d2-8e31-d28a2209e383
Set id: 41891599-420e-48d2-8e31-d28a2209e383
Version: 1
Effective Time: 20110203
 
Purdue Products LP