- Active ingredient Purpose
- PURPOSE
- INDICATIONS & USAGE
- Warnings
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DOSAGE & ADMINISTRATION
DirectionsFor use in the ear only.
Adults and children over 12 years of age:
• tilt head sideways and place 5 to 10 drops into ear
• tip of applicator 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 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 years of age: consult a doctor. - INACTIVE INGREDIENT
- Questions?1-866-483-2846
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EAR DROPS
carbamide peroxide 6.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-508 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 6.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Sodium Lauroyl Sarcosinate (UNII: 632GS99618) Sodium Stannate (UNII: NJ7C1V83KG) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-508-01 1 in 1 CARTON 09/01/2017 1 15 mL in 1 BOTTLE; 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 09/01/2017 Labeler - Good Sense (076059836) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(50804-508) , label(50804-508)