Label: QUIP ANTICAVITY FLUORIDE CONCENTRATE- 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 December 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (diluted solution)

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

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use

    Aids in prevention of dental cavities

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Do not use before mixing with water
    • Measure 2.5ml. Dilute with water to 4x volume (10ml). Use immediately
    • Adults and children 6 years of age and older:
    • Use once a day after brushing your teeth with a toothpaste
    • Vigorously swish 10ml 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
    • Supervise children as necessary until capable of using without supervision
    • Children under 6 years of age: consult a dentist or doctor
  • STORAGE AND HANDLING

    Other information

    • Do not store the diluted product
    • Store concentrate at room temperature
    • Do not use if seal under cap is broken or missing.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Xylitol, Erythritol, Polysorbate 20, Flavor, Sucralose, Disodium EDTA, Cetylpyridinium Chloride, Sodium Hydroxide

  • SPL UNCLASSIFIED SECTION

    Distributed by: quip NYC Inc., 45 Main Street, Brooklyn, NY 11201, USA

    Questions? hello@getquip.com

  • BOTTLE

    Anticavity Fluoride Mouthwash Refill
    Mint
    CONCENTRATE 4x 470mL DILUTED
    QUIP
    117.5 ML (3.97 FL OZ)

    IMPORTANT: Read directions for proper use

    201215 Hudson_BOTTLE

  • RETAIL CARTON

    QUIP

    CONCENTRATE 4x 470mL DILUTED

    • Kills bad breath germs
    • Freshens breath
    • Strengthens teeth
    • Helps prevent cavities
    • Alcohol-free formula
    • Vegan-friendly

    Anticavity Fluoride Mouthwash Refill
    Mint
    117.5 ML (3.97 FL OZ)
    IMPORTANT: Read directions for proper use 201215 Hudson Retail Refill_CARTON

  • STARTER KIT

    QUIP

    Mouthwash Starter Kit

    Refillable Dispenser & Cup

    One pump for perfect daily dose

    Mint Anticavity Fluoride Mouthwash Refill

    Kills bad breath germs
    Freshens breath
    Strengthens teeth
    Helps prevent cavities
    Alcohol-free formula
    Vegan-friendly

    4X CONCENTRATE 470mL DILUTED

    117.5 ML (3.97 FL OZ)
    IMPORTANT: Read directions for proper use

    201215_Hudson_PACKAGE

  • INGREDIENTS AND APPEARANCE
    QUIP ANTICAVITY FLUORIDE  CONCENTRATE
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69261-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ERYTHRITOL (UNII: RA96B954X6)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Product Characteristics
    Coloryellow (Clear to Yellow Clear) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69261-005-041 in 1 CARTON01/25/2021
    1117.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:69261-005-03117.5 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2021
    3NDC:69261-005-051 in 1 PACKAGE01/25/2021
    3117.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/25/2021
    Labeler - Quip NYC Inc. (079453380)
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