Label: BETADINE SURGICAL SCRUB- povidone-iodine solution
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NDC Code(s):
67618-151-01,
67618-151-04,
67618-151-16,
67618-151-17, view more67618-151-32
- 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 17, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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DOSAGE & ADMINISTRATION
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Surgical hand scrub:
- wet hands with water
- spread about 5 cc (1 teaspoonful) of Scrub over both hands and forearms
- without adding more water, scrub thoroughly for 2 1/2 to 3 minutes
- use a sponge if desired. Clean thoroughly under fingernails.
- add a little water and develop copious suds. Rinse thoroughly under running water.
- repeat the entire procedure using another 5 cc of Scrub
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Antiseptic hand wash:
- wet hands with water and pour about 5 cc of Scrub on hands
- rub hands vigorously together for at least 15 seconds, covering all surfaces
- rinse and dry with a disposable towel
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Surgical hand scrub:
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BETADINE SURGICAL SCRUB
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-151 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE .075 mg in 1 mL Inactive Ingredients Ingredient Name Strength AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67618-151-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/1996 2 NDC:67618-151-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/1996 3 NDC:67618-151-17 1 in 1 CARTON 07/01/1996 3 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:67618-151-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/1996 11/30/2024 5 NDC:67618-151-01 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/1996 Labeler - Avrio Health L.P. (141916531) Registrant - Purdue Pharma LP (932323652) Establishment Name Address ID/FEI Business Operations Thatcher Company 041307356 MANUFACTURE(67618-151)