Label: REACH ANTI CAVITY FLUORIDE- sodium fluoride rinse

  • NDC Code(s): 66923-300-08, 66923-300-64
  • Packager: Ranir LLC
  • 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 June 27, 2022

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  • Active ingredient

    Sodium fluoride 0.02% (0.01% w/v fluoride ion)

  • Purpose

    Anticavity rinse

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 6 years of age and older:

    •
    use once a day after brushing your teeth with a toothpaste
    •
    vigorously swish 10 mL of rinse between your teeth for 1 minute and then spit out
    •
    do not swallow the rinse
    •
    do not eat of drink for 30 minutes after rinsing
    •
    instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    •
    supervise children as necessary until capable of using without supervision

    Children under 6 years of age: consult a dentist or doctor

  • Other information

    •
    store at room temperature 59-86°F (15-30°C)
    •
    cold weather may temporarily cloud product, shake well if this occurs
    •
    do not use if printed safety seal is broken or missing.
  • Inactive ingredients

    purified water, glycerin, propylene glycol, PEG-40 hydrogenated castor oil, poloxamer 407, sodium benzoate, flavor, cetylpyridinium chloride, sucralose, citric acid, disodium phosphate, FD&C blue #1

  • Questions?

    1-866-373-7374 or comments@ranir.com

  • Package/Label Principal Display Panel

    REACH® ESSENTIALS™

    ANTI-CAVITY

    FLUORIDE RINSE

    6 IN 1 BENEFITS

    - Freshens Breath

    - Cleans Mouth

    - Strengthens Teeth

    - Fights Acid Wear

    - Prevents Cavities

    - Alcohol-Free

    ARCTIC MINT

    IMPORTANT: Read directions for proper use

    13.5 FL OZ (400 mL)

    reach-anticavity-fluoride-rinse-front
    reach-anticavity-fluoride-rinse-back
  • INGREDIENTS AND APPEARANCE
    REACH ANTI CAVITY FLUORIDE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66923-300
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66923-300-08400 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2021
    2NDC:66923-300-641000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/22/2021
    Labeler - Ranir LLC (364567615)
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