DrugCite

BETADINE - povidone-iodine solution 
Purdue Products LP

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 NDC Product Code (Source) 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
# NDC Package Description Multilevel Packaging
1 67618-150-05 14.8 mL In 1 BOTTLE None
2 67618-150-04 118 mL In 1 BOTTLE None
3 67618-150-08 237 mL In 1 BOTTLE None
4 67618-150-09 237 mL In 1 BOTTLE None
5 67618-150-16 473 mL In 1 BOTTLE None
6 67618-150-17 473 mL In 1 BOTTLE None
7 67618-150-32 946 mL In 1 BOTTLE None
8 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: 02/2011Purdue Products LP