Label: CLINERE EAR WAX REMOVER- carbamide peroxide liquid
- NDC Code(s): 68229-102-01, 68229-102-02, 68229-102-03
- Packager: Quest Products
- 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 March 4, 2022
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- Active Ingredient
For use in the ear only
Ask a Doctor before use if you have
- ear drainage or discharge
- ear pain
- irritation or rash in the ear
- an injury or perforation (hole) of the eardrum
- recently had ear surgery
Stop use and ask a Doctor if
- you need to use for more than four days
- excessive earwax remains after use of this product
FOR USE IN THE EAR ONLY.
Adults and children over 12 years of age:
- tilt head sideways and place 5-10 drops into each 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 ear.
- Use twice daily for up to four days if needed, or as directed by a doctor.
- Any wax remaining in the ear may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe, or by use of the included Clinere® ear cleaning tool. (See separate directions)
Children under 12 years: Consult a doctor.
- Other Information
- Inactive Ingredients
- Clinere® Earwax Removal Kit w/4 Clinere® Ear Cleaners and 1 x 0.5 Fl Oz Carbamide Peroxide Bottle
INGREDIENTS AND APPEARANCE
CLINERE EAR WAX REMOVER
carbamide peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68229-102 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 0.065 g in 1 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM CITRATE (UNII: 1Q73Q2JULR) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68229-102-03 2 in 1 CARTON 03/04/2022 1 NDC:68229-102-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68229-102-02 1 in 1 CARTON 03/04/2022 2 NDC:68229-102-01 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 03/04/2022 Labeler - Quest Products (075402441)