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Betadine

Purdue Products LP
Purdue Products LP

Betadine Solution Swabsticks Povidone-iodine Solution USP, 10%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient Purpose

Povidone-iodine Solution USP, 10% (equal to 1% available iodine)

Purpose

Antiseptic

Betadine Uses

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

Warnings

For external use only

Do not use this product

  • in the eyes
  • if you are allergic to iodine or other product ingredients

When using this product

  • prolonged exposure may cause irritation or, rarely, severe skin reactions

Stop using this product

  • in rare instances of local irritation or sensitivity
  • if irritation and redness develop and continue for more than 72 hours

Keep out of reach of children

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

Directions

  • tear at slit; pull top of packette across, exposing end of swabstick
  • remove Betadine Solution Swabstick and apply as needed
  • use one time only

Betadine Other information

  • store between 20°-25°C (68°-77°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, purified water, sodium hydroxide

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

L01119B 301880-0A

Betadine Solution Swabsticks
NDC 67618-153-01

Betadine

Betadine Solution Swabsticks
NDC 67618-153-03

Betadine

Betadine

POVIDONE-IODINE SWAB

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67618-153
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
CITRIC ACID MONOHYDRATE
sodium phosphate, dibasic, dihydrate
NONOXYNOL-9
water
SODIUM HYDROXIDE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-153-01 1 in 1 PACKET
2 NDC:67618-153-03 3 in 1 PACKET

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 1972-09-15


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