Label: EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid
- NDC Code(s): 52412-600-05
- Packager: Randob Labs, Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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DOSAGE & ADMINISTRATION
FOR USE IN THE EAR ONLY
Adults & Children over 12 yrs of age:
Tilt head to the side and place 5-10 drops into ear.
Dropper tip of removal drops should not enter ear canal.
Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
Use twice daily for up to four days if needed, or as directed by a doctor.
Safely scoop out wax with removal tool.
Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.
Children under 12 yrs of age:
Consult a doctor.
- INDICATIONS & USAGE
- PURPOSE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- WHEN USING
- STOP USE
- OTHER SAFETY INFORMATION
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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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:52412-600 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 CHAMOMILE (UNII: FGL3685T2X) OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P) MINERAL OIL (UNII: T5L8T28FGP) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52412-600-05 1 in 1 CARTON 07/03/2020 1 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 Drug M014 07/03/2020 Labeler - Randob Labs, Ltd. (061995007) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(52412-600) , analysis(52412-600) , label(52412-600) , pack(52412-600)