Label: EQUATE BEAUTY ENAMEL PROTECTION GENTLE WHITENING FOR SENSITIVE TEETH- potassium nitrate, sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 26, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.15% w/v fluoride ion

  • PURPOSE

    Purpose

    Antihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

    Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities
  • WARNINGS

    Warnings

    When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

    See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrus

    • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
    • Do not swallow
    • Children under 12 years of age: consult a dentist or physician.
  • SPL UNCLASSIFIED SECTION

    Other information Store in a cool, dry place · Keep tube capped when not in use.

  • INACTIVE INGREDIENT

    Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Satisfaction guaranteed - Or we'll replace it or give you your money back. For questions or comments please call 1-888-287-1915.

    DISTRIBUTED BY:

    Walmart Inc.

    Bentonville, AR 72716

    †Guards your teeth against sensitivity and the effects of acid wear through normal brushing.

  • PRINCIPAL DISPLAY PANEL

    equate

    ENAMEL PROTECTION GREEN MINT FLAVOR

    GENTLE WHITENING FOR SENSITIVE TEETH

    DAILY ANTI-CAVITY TOOTHPASTE WITH FLUORIDE

    Helps harden tooth enamel with acid protection formula †

    NET WT 4.0 OZ (113g)

    EquateEnamelMint R1

  • INGREDIENTS AND APPEARANCE
    EQUATE BEAUTY ENAMEL PROTECTION GENTLE WHITENING FOR SENSITIVE TEETH 
    potassium nitrate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-861
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-861-891 in 1 BOX11/02/2018
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/02/2018
    Labeler - Wal-Mart Stores Inc (051957769)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(49035-861)
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