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Major Povidone Iodine

Medically reviewed by Drugs.com. Last updated on Jul 3, 2018.

Dosage form: ointment
Ingredients: POVIDONE-IODINE 100mg in 1g
Labeler: Major Pharmaceuticals
NDC Code: 0904-1102

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.

DRUG FACTS

Active ingredient

Povidone Iodine USP10% w/w (available iodine 1%)

Purpose

Antiseptic-germicidal

Uses

for the treatment of:

  • minor wounds
  • infections
  • kills bacteria promptly

Warnings

For external use only.

Do not use
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

When using this product
  • Avoid contact with eyes.

Ask a doctor before use if you have
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if
  • redness, irritation or swelling occurs or pain persists

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions
  • apply directly to affected area
  • may be bandaged

Other information
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
  • For control no. and expiration date, see carton and/or crimp of tube.
  • Will not stain natural fabrics.
  • Protect from freezing.

Inactive ingredients

glycerin, PEG-6, PEG-32, propylene glycol

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS

31778 Enterprise Drive, Livonia, Ml 48150 USA

Re-Oder No. 100433 M-101

Principal Display Panel – 1 oz. Tube

Major® NDC 0904-1102-31

Povidine™

FIRST AID OINTMENT

NET WT. 1 OZ (28.35 g) *Compare to

POVIDINE – IODINE 10% Active Ingredient of

AVAILABLE IODINE 1% Betadine® Ointment

Principal Display Panel – 1 oz. Carton

Major® NDC 0904-1102-31

Povidine™ *Compare to

FIRST AID OINTMENT Active Ingredient of

NET WT. 1OZ (28.35 g) POVIDINE - IODINE 10% Betadine® Ointment

MAJOR POVIDONE IODINE 
povidone-iodine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOL 300 
POLYETHYLENE GLYCOL 1500 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:0904-1102-311 TUBE in 1 CARTON
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/14/2006
Labeler - Major Pharmaceuticals (191427277)
Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(0904-1102)

 
Major Pharmaceuticals

Further information

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

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