Label: QUIP ANTICAVITY- sodium fluoride paste, dentifrice

  • 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 May 12, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.24% (0.14% 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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Use only a pea-sized amount and instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision
    • Children under 2 years of age: consult a dentist or doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Glycerin, Water, Hydrated Silica, Sorbitol, Erythritol, Sodium Lauroyl Sarcosinate, Flavor, Xylitol, Cellulose Gum, Sucralose, Titanium Dioxide

  • SPL UNCLASSIFIED SECTION

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

    Questions? hello@getquip.com

  • Carton

    quip

    Toothpaste

    Anticavity Fluoride

    Xylitol, vegan, SLS-free formula

    Mint

    180 USES PER TUBE

    NET WT 4.7 OZ (133G)

    Quip Mint 12-2020

  • Tube

    Anticavity Fluoride Toothpaste

    Mint

    quip

    NET WT 4.7 OZ (133G)

    2012 quip Mint

  • INGREDIENTS AND APPEARANCE
    QUIP ANTICAVITY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69261-006
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 2300 MPA.S AT 1%) (UNII: 0Z2R7OG99L)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69261-006-011 in 1 CARTON01/25/2021
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69261-006-06133 g in 1 TUBE; Type 0: Not a Combination Product01/25/2021
    3NDC:69261-006-081 in 1 CARTON07/15/2021
    3130 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:69261-006-07130 g in 1 TUBE; Type 0: Not a Combination Product07/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/25/2021
    Labeler - Quip NYC Inc. (079453380)