Label: PEPPERMINT TWIST- fluoride paste, dentifrice
- NDC Code(s): 34362-0237-2
- Packager: Caldwell Health LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Adults and children 2 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice or as directed by a dentist or physician. Children 2 to 6 years Use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years Ask a dentist or physician. - STORAGE AND HANDLING
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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.
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INGREDIENTS AND APPEARANCE
PEPPERMINT TWIST
fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34362-0237 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Color white (Off White) Score Shape Size Flavor PEPPERMINT (Peppermint Twist) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:34362-0237-2 1 in 1 BOX 04/11/2018 1 142 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 04/11/2018 Labeler - Caldwell Health LLC (828558713) Registrant - GORAN PHARMA PRIVATE LIMITED (862174088) Establishment Name Address ID/FEI Business Operations GORAN PHARMA PRIVATE LIMITED 862174088 manufacture(34362-0237)