Label: EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid
- NDC Code(s): 0395-9132-45
- Packager: Humco Holding Group, 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.
Updated March 17, 2022
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DOSAGE & ADMINISTRATION
Adults & Children over 12 yrs of age:
tilt head to the side and place 10 drops into the ear canal.
Tip of applicator should not enter into the ear canal
Keep drops in ear for several minutes by keeping head tilted sideways or placing cotton in the ear.
Use twice daily for up to 4 days if needed, or as directed by a doctor.
Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
Children under 12 yrs of age:
Consult a physician.
- INDICATIONS & USAGE
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EARWAX REMOVAL DROPS
carbamide peroxide 6.5% liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9132 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) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9132-45 1 in 1 CARTON 06/05/2019 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 final part344 06/05/2019 Labeler - Humco Holding Group, Inc (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-9132) , analysis(0395-9132) , label(0395-9132) , pack(0395-9132)