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Betadine

Purdue Products LP

Betadine Solution 10% Povidone-iodine


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Betadine 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

Betadine

POVIDONE-IODINE SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67618-150
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POVIDONE-IODINE IODINE .01 mL

Inactive Ingredients

Ingredient Name Strength
AMMONIUM NONOXYNOL-4 SULFATE
NONOXYNOL-9
water
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-150-05 14.8 in 1 BOTTLE
2 NDC:67618-150-04 118 in 1 BOTTLE
3 NDC:67618-150-08 237 in 1 BOTTLE
4 NDC:67618-150-09 237 in 1 BOTTLE
5 NDC:67618-150-16 473 in 1 BOTTLE
6 NDC:67618-150-17 473 in 1 BOTTLE
7 NDC:67618-150-32 946 in 1 BOTTLE
8 NDC:67618-150-01 3780 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 1996-07-15


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