Label: MURINE EAR WAX REMOVAL DROPS- carbamide peroxide liquid
- NDC Code(s): 67172-361-01, 67172-361-02
- Packager: Prestige Brands Holdings, 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.
Drug Label Information
Updated October 18, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Ask a doctor before use
- if you have ear drainage or discharge, ear pain, irritation, a rash in the ear or are dizzy
- if you have an injury or perforation (hole) of the eardrum or after ear surgery
- if you have ear drainage or discharge, ear pain, irritation, a rash in the ear or are dizzy
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Directions
FOR USE IN THE EAR ONLY. Remove any hearing aids before using this product.
- Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear canal.
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. The tip of the ear syringe should not obstruct the flow of fluid leaving the ear.
Children under 12 years of age: consult a doctor.
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Other information
- Murine® Ear Drops foam upon being placed in the ear due to the release of oxygen.
- This product is not intended to restore hearing loss due to medical reasons. In such cases, consult a doctor.
- Protect from heat and sunlight. Secure cap tightly on bottle when not in use.
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Tamper-Evident: Do not use if neckband on bottle is broken or missing.
- Check expiration date before using.
- Murine® Ear Drops foam upon being placed in the ear due to the release of oxygen.
- Inactive ingredients
- Questions? 1-877-854-0853
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MURINE EAR WAX REMOVAL DROPS
carbamide peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-361 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 65 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM CITRATE (UNII: 1Q73Q2JULR) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-361-01 1 in 1 CARTON 06/01/2012 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:67172-361-02 1 in 1 CARTON 06/01/2012 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 06/01/2012 Labeler - Prestige Brands Holdings, Inc. (159655021)
