Label: PEPPERMINT TWIST- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride (0.24%) (0.15% 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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and olderBrush teeth thoroughly, preferably after each meal or at least twice or as directed by a dentist or physician.
    Children 2 to 6 yearsUse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    Children under 2 yearsAsk a dentist or physician.

  • STORAGE AND HANDLING

    Other information

    Store standing up with cap tightly closed.

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, hydrated silica, sorbitol, water, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoylglycinate, cellulose gum, titanium dioxide, Echinacea angustifolia extract, natural flavors (contains Cinnamomum cassie leaf oil), Hydrastis canadensis (goldenseal) extract, Calendula officinalis extract, xanthan gum, citric acid, zinc citrate, Citrus grandis (grapefruit) seed extract.

  • QUESTIONS

    Questions? Call 1-888-317-4402, weekdays 9 to 5 ET.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Revive Personal Products Company,

    Allendale, NJ 07401

    © 2018 Revive Personal Products Company.
    Made in USA. Vegan. Not tested on animals.

  • PRINCIPAL DISPLAY PANEL

    NO SLS!

    THE NATURAL DENTIST

    ALL IN ONE

    FLUORIDE TOOTHPASTE

    with Purified Aloe Vera

    • Prevents Cavities
    • Whitens Teeth
    • Strengthens Tooth Enamel
    • Fights Tartar
    • Freshens Breath

    PEPPERMINT TWIST

    NET WT. 5.0 OZ (141g)

    image description

  • INGREDIENTS AND APPEARANCE
    PEPPERMINT TWIST 
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0237
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    CITRUS MAXIMA SEED (UNII: 083X55C543)  
    Product Characteristics
    Colorwhite (Off White) Score    
    ShapeSize
    FlavorPEPPERMINT (Peppermint Twist) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34362-0237-21 in 1 BOX04/11/2018
    1142 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02204/11/2018
    Labeler - Caldwell Health LLC (828558713)
    Registrant - GORAN PHARMA PRIVATE LIMITED (862174088)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORAN PHARMA PRIVATE LIMITED862174088manufacture(34362-0237)
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