Label: FAMILY CARE EARWAX REMOVAL- carbamide peroxide 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.

Drug Label Information

Updated March 31, 2022

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Carbamide peroxide 6.5%.................................Ear wax removal

  • PURPOSE

    Uses

    For occasional use as an aid to soften, loosen, and remove excessive ear wax.

  • WARNINGS

    Warnings

    Ask a doctor before use if you have

    • ear drainage or discharge
    • ear pain
    • dizziness
    • irritation or rash in the ear
    • recently had ear surgery
    • an injury or perforation (hole) of the eardrum
  • STOP USE

    Stop use and ask a doctor if

    • you need to use for more than four days
    • excessive earwax remains after use of this product
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    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 way 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: consult a doctor
  • STORAGE AND HANDLING

    Other information

    • do not store above 25°C (77°F)
    • store bottle in the outer carton
    • product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound
    • keep cap on bottle when not in use
  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid monohydrate, flavor, glycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, sodium stannate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    Cypress, CA 90630

    Made in China

  • PRINCIPAL DISPLAY PANEL

    639.1

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE EARWAX REMOVAL 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-639
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-639-151 in 1 CARTON10/22/2019
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/22/2019
    Labeler - United Exchange Corp. (840130579)
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