Label: EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid
- NDC Code(s): 82645-910-45, 82645-910-90
- Packager: Pharma Nobis, LLC
- 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 December 30, 2022
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- INACTIVE INGREDIENT
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- DOSAGE & ADMINISTRATION
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- ACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
EARWAX REMOVAL DROPS
carbamide peroxide 6.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82645-910 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 0.065 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM STANNATE (UNII: NJ7C1V83KG) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82645-910-90 1 in 1 CARTON 06/04/2019 1 15 mL in 1 CONTAINER; Type 0: Not a Combination Product 2 NDC:82645-910-45 1 in 1 CARTON 06/04/2019 2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 06/04/2019 Labeler - Pharma Nobis, LLC (118564114) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(82645-910) , analysis(82645-910) , pack(82645-910) , label(82645-910)