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Betadine

Purdue Products LP

Betadine Spray Povidone-iodine, 5%


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Povidone-iodine, 5% (0.5% available iodine).

Purpose

Antiseptic

Uses

Patient pre-operative skin preparation

  • 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

  • hold container about 4-6 inches from skin
  • spray desired area n allow to dry
  • may be bandaged
  • replace cap after use

Betadine Other information

  • store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). Do not freeze.

Inactive ingredients

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water

Dist. by: Purdue Products L.P., Stamford, CT 06901-3431
301821-0B



Betadine Spray
NDC 67618-148-03

Betadine

Betadine

POVIDONE-IODINE SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67618-148
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
POVIDONE-IODINE IODINE .05 mL

Inactive Ingredients

Ingredient Name Strength
Citric acid
SODIUM PHOSPHATE, DIBASIC
GLYCERIN
NONOXYNOL-9
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67618-148-03 89 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 1992-04-15


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