Label: EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE- carbamide peroxide liquid
- NDC Code(s): 61715-031-74
- Packager: Kinray Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Carbamide Peroxide 6.5%Close
Softens and Loosens WaxClose
- INDICATIONS & USAGE
Safely and gently removes ear wax.Close
Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor. If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor. For more than four consecutive days.
When using this product: avoid contact with the eyes.
Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.Close
- DOSAGE & ADMINISTRATION
FOR 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 ear. Use twice daily for up to four 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.Close
- INACTIVE INGREDIENT
Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower OilClose
- PRINCIPAL DISPLAY PANEL
Ear Wax Removal System
- INGREDIENTS AND APPEARANCE
EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE
preferred plus liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-031 Route of Administration AURICULAR (OTIC) DEA Schedule 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 GLYCERIN (UNII: PDC6A3C0OX) OXYQUINOLINE (UNII: 5UTX5635HP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-031-74 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 03/15/2013 Labeler - Kinray Inc (012574513)