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Betadine by Purdue Products LP

Medically reviewed on January 31, 2018

Dosage form: spray
Ingredients: POVIDONE-IODINE .05mL in 1mL
Labeler: Purdue Products LP
NDC Code: 67618-148

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.

Betadine Spray

Povidone-iodine, 5%

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

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 
povidone-iodine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-148
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE.05 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID 
SODIUM PHOSPHATE, DIBASIC 
GLYCERIN 
NONOXYNOL-9 
WATER 
Packaging
#Item CodePackage Description
1NDC:67618-148-0389 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/15/1992
Labeler - Purdue Products LP (141916531)
Establishment
NameAddressID/FEIOperations
Thatcher Company041307356MANUFACTURE

 
Purdue Products LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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