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 Type HUMAN OTC DRUG Item Code (Source) NDC:67618-150
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE .01 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-150-05 14.8 mL in 1 BOTTLE
2 NDC:67618-150-04 118 mL in 1 BOTTLE
3 NDC:67618-150-08 237 mL in 1 BOTTLE
4 NDC:67618-150-09 237 mL in 1 BOTTLE
5 NDC:67618-150-16 473 mL in 1 BOTTLE
6 NDC:67618-150-17 473 mL in 1 BOTTLE
7 NDC:67618-150-32 946 mL in 1 BOTTLE
8 NDC:67618-150-01 3780 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 07/15/1996
Labeler - Purdue Products LP (141916531)
Establishment
Name Address ID/FEI Business Operations
Thatcher Company 041307356 MANUFACTURE

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