Label: GOOD NEIGHBOR PHARMACY EARWAX REMOVAL DROPS- carbamide peroxide liquid
- NDC Code(s): 71205-260-15
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 46122-557
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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- Drug Facts
- Active ingredient
- Uses
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Warnings
For use in the ear only
Ask a doctor beofre use if you have
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- ear drainage or discharge
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- ear pain
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- irritation, or rash in the ear
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- dizziness
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- an injury or perforation (hole) of the ear drum
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- recently had ear surgery
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Directions
FOR USE IN THE EAR ONLY
Adults and children over 12 years of age:
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- Tilt head sideways and place 5 to 10 drops into ear
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- Tip of applicator should not enter ear canal
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- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
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- Use twice daily for up to 4 days if needed, or as directed by a doctor
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- Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
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- Children under 12 years: consult a doctor
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Other information
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- Avoid exposing bottle to excessive heat and direct sunlight
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- Store bottle in the outer carton
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- Keep cap on bottle when not in use
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- Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
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- Do not use if tamper-evident safety seal is broken or missing
- Inactive ingredients
- Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY EARWAX REMOVAL DROPS
carbamide peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-260(NDC:46122-557) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 65 mg in 1 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-260-15 1 in 1 CARTON 05/01/2019 1 15 mL in 1 BOTTLE, DISPENSING; 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 01/01/2019 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-260) , RELABEL(71205-260)