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


Betadine Solution10% Povidone-iodine

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

  • clean the operative site prior to surgery
  • apply product and allow to dry
  • may be covered with a bandage

Other information

  • store at 25°C (77°F); excursions permitted between15°-30°C (59°-86°F)
  • store in original container

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 (POVIDONE-IODINE) POVIDONE-IODINE .01 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:67618-150-05 14.8 mL in 1 BOTTLE None
2 NDC:67618-150-04 118 mL in 1 BOTTLE None
3 NDC:67618-150-08 237 mL in 1 BOTTLE None
4 NDC:67618-150-09 237 mL in 1 BOTTLE None
5 NDC:67618-150-16 473 mL in 1 BOTTLE None
6 NDC:67618-150-17 473 mL in 1 BOTTLE None
7 NDC:67618-150-32 946 mL in 1 BOTTLE None
8 NDC:67618-150-01 3780 mL in 1 BOTTLE None

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 Operations
Thatcher Company 041307356 MANUFACTURE

Revised: 02/2011 Purdue Products LP



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


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