EARWAX REMOVAL DROPS EQUATE (CARBAMIDE PEROXIDE 6.5%) LIQUID [WALMART]

EARWAX REMOVAL DROPS EQUATE (CARBAMIDE PEROXIDE 6.5%) LIQUID [WALMART]
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NDC 49035-537-01
Set ID 4b601252-9b3b-4022-83b4-ca437254e4d9
Category HUMAN OTC DRUG LABEL
Packager Walmart
Generic Name
Product Class
Product Number
Application Number PART344
  • Active ingredient                        Purpose

    Carbamide peroxide  6.5%          Earwax removal aid

  • PURPOSE

  • INDICATIONS & USAGE

    For occasional use as an aid to soften, loosen and remove excessive earwax

  • 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 ear drum or after ear surgery, unless
    directed by a doctor • for more than 4 consecutive
    days; if excessive earwax remains after use of this
    product, consult a doctor

    When using this product • avoid contact with eyes.
    If accidental contact with eyes occurs, flush eyes
    with water and consult a doctor

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    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 the ear. Use twice daily for up to 4
    days if needed, or as directed by a doctor. • Any wax
    remaining after the 4-day 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

    Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL DROPS   EQUATE
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-537
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-537-011 in 1 CARTON06/05/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34406/05/2017
    Labeler - Walmart (051957769)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(49035-537) , label(49035-537)

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