NDC | 67172-361-01, 67172-361-02 |
Set ID | 1cce035e-209b-44d8-bad3-5789f26bd31b |
Category | HUMAN OTC DRUG LABEL |
Packager | Prestige Brands Holdings, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART344 |
- 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)