Label: BIOTRONIX HEALTHCARE- povidone iodine sponge
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Contains inactivated NDC Code(s)
NDC Code(s): 71389-101-01 - Packager: Biotronix Healthcare Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 6, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STOP USE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOTRONIX HEALTHCARE
povidone iodine spongeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71389-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) NONOXYNOL-10 (UNII: K7O76887AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71389-101-01 20 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 05/03/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 05/03/2018 Labeler - Biotronix Healthcare Industries, Inc. (065762392)