Label: EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE- leader liquid
- 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.
Updated January 11, 2012
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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.
- KEEP OUT OF REACH OF CHILDREN
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.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-615 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbamide Peroxide (UNII: 31PZ2VAU81) (Carbamide Peroxide - UNII:31PZ2VAU81) Carbamide Peroxide 6.5 g in 100 mL Inactive Ingredients Ingredient Name Strength Aloe Vera Leaf (UNII: ZY81Z83H0X) CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-615-56 1 in 1 PACKAGE, COMBINATION 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 12/01/2011 Labeler - Cardinal Health (097537435)