Label: BETADINE CREAM- povidone-iodine cream
- NDC Code(s): 67618-180-12
- Packager: Avrio Health L.P.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated December 15, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings For external use only
- in the eyes
- over large areas of the body
- if you are allergic to povidone-iodine or any other ingredients in this preparation
Ask a doctor before use if you have
- deep or puncture wounds
- serious burns
- animal bites
- the condition persists or gets worse
- you need to use this product for more than 1 week
- WHEN USING
- HOW SUPPLIED
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BETADINE CREAM
povidone-iodine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 0.05 mg in 1 mL Inactive Ingredients Ingredient Name Strength cetostearyl alcohol (UNII: 2DMT128M1S) glycerin (UNII: PDC6A3C0OX) mineral oil (UNII: T5L8T28FGP) PEG-50 stearate (UNII: 776CJK5X56) polysorbate 60 (UNII: CAL22UVI4M) potassium iodate (UNII: I139E44NHL) sodium hydroxide (UNII: 55X04QC32I) sorbitan monostearate (UNII: NVZ4I0H58X) water (UNII: 059QF0KO0R) petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67618-180-12 1 in 1 CARTON 06/01/1980 1 15 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/1980 Labeler - Avrio Health L.P. (141916531) Registrant - Purdue Pharma LP (932323652) Establishment Name Address ID/FEI Business Operations Mundipharma Pharmaceuticals Limited 365982441 MANUFACTURE(67618-180)