Label: EQUATE ANTICAVITY ORAL RINSE- fluoride liquid

  • Category: HUMAN OTC DRUG LABEL

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 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.021%

    (0.01% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 6 years and older: use twice a day after brushing your teeth with a toothpaste
    • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • supervise childrenas necessary until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredients water, glycerin, flavor, cetylpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, red 33, green3

  • QUESTIONS

    Questions? Call 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

    PRODUCT OF CANADA

  • PRINCIPAL DISPLAY PANEL

    equate™

    Anticavity Oral Rinse

    Multi-Action with Fluoride

    33.8 FL OZ (1L)

    Anticavity Oral Rinse

  • INGREDIENTS AND APPEARANCE
    EQUATE ANTICAVITY ORAL RINSE 
    fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.021 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Product Characteristics
    ColorpurpleScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-535-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/05/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!