Label: ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash

  • 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 August 5, 2016

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  • Active ingredient

    Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity Rinse

  • Use

    aids in the prevention of dental cavities

  • Warning

    for this product only

  • Keep out of reach of children

    If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
    • remove cap
    • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
    • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
    • do now 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 children as necessay until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • other information

    • store at room temperature
  • inactive ingredients

    benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, green 3, menthol, methyl salicylate, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water, yellow 5.

  • Questions?

    Call 1-888-593-0593

  • ADA Council Statement

    "The ADA Council on Scientific Affairs Acceptance of HEB Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."

  • Disclaimer

    This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Mouthwash

  • TEP

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

  • Adverse reactions

    MADE WTH PRIDE AND CARE FOR H-E-B SAN ANTONIO, TX 78204

  • Principal Display Panel

    Compare to ACT Anticavity

    Fluoride Mouthwash

    H-E-B

    Mint

    ANTICAVITY

    FLUORIDE

    MOUTH RINSE

    ADA

    Accepted

    American

    Dental

    Association

    • Helps Prevent Cavities
    • Alcohol Free
    • Freshens Breath

    IMPORTANT: read directions for proper use.

    18 FL OZ (1.1 PT) 532 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    menthol (UNII: L7T10EIP3A)  
    methyl salicylate (UNII: LAV5U5022Y)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/21/2016
    Labeler - HEB (007924756)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(37808-213)
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