QUIP (SODIUM FLUORIDE) PASTE, DENTIFRICE [QUIP NYC INC.]

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QUIP (SODIUM FLUORIDE) PASTE, DENTIFRICE [QUIP NYC INC.]
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NDC 69261-004-01, 69261-004-02
Set ID 7c11b3f1-84a3-f336-e053-2991aa0afc2a
Category HUMAN OTC DRUG LABEL
Packager Quip NYC Inc.
Generic Name
Product Class
Product Number
Application Number PART355
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride 0.23% (0.12% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    Aids in 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 Centre right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as instructed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
    • children under 2 years: ask a dentist
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Sorbitol, Hydrated Silica, Glycerin, Xylitol, Flavor, Cellulose Gum, Sodium Lauroyl Sarcosinate, Sodium Saccharin, Carrageenan, Titanium Dioxide, Hydrogen Peroxide, Menthol

  • SPL UNCLASSIFIED SECTION

    Distributor: quip NYC Inc., 45 Main St, Brooklyn, NY 11201, USA

    Made in: USA

    Expiry: 2 years from the manufacturing date shown on crimp

    Email: help@getquip.com

  • PRINCIPAL DISPLAY PANEL

    3 MONTHS

    NET WT 4.7 oz (133g)

    QUIP

    watermelon anticavity toothpaste

    181116 QUIP - 133g

  • INGREDIENTS AND APPEARANCE
    QUIP 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69261-004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.23 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)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69261-004-01133 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    2NDC:69261-004-0224 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/01/2019
    Labeler - Quip NYC Inc. (079453380)
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