Label: HARRIS TEETER EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid
- NDC Code(s): 69256-117-01
- Packager: Harris Teeter LLC
- 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 April 27, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 4 days; if excessive earwax remains after use of this product, consult a doctor
When using this product avoid contact with the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
FOR IN EAR USE 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 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. Children under 12 years of age: consult a doctor.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HARRIS TEETER EARWAX REMOVAL DROPS
carbamide peroxide 6.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69256-117 Route of Administration TOPICAL 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CITRATE (UNII: 1Q73Q2JULR) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69256-117-01 1 in 1 CARTON 04/27/2022 1 15 mL in 1 BOTTLE; 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 04/27/2022 Labeler - Harris Teeter LLC (048463103) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(69256-117)
