EARLY BIRD WINTERGREEN AND PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [TWICE SMILES LLC]

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EARLY BIRD WINTERGREEN AND PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [TWICE SMILES LLC]
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NDC 72164-001-00
Set ID 10743960-2a60-4a2f-a024-8e3b79b0d118
Category HUMAN OTC DRUG LABEL
Packager Smiletwice, Inc.
Generic Name
Product Class
Product Number
Application Number PART356
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  • Drug Facts

  • Active ingredients

    Potassium Nitrate 5%
    Sodium Fluoride 0.240% (0.15% w/v Fluoride ion)

    Purpose

    Antihypersensitivity

    Anticavity

  • Uses

    Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    Aids in prevention of dental cavities.

  • Warnings

    When using this product,

    if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

    Stop use and ask a dentist

    if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    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.

  • Directions

    Adults and children 12 years of age and older: Apply at least 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day (morning and night) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. · Children under 12 years: consult a dentist or doctor.

  • Inactive Ingredients

    Water, Hydrated Silica, Sorbitol, Glycerin, Pentasodium Triphosphate, Cocamidopropyl Betaine, Flavor, Sodium Acorbyl Phosphate (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopherol (Vitamin E), Aloe Barbadensis Leaf Juice (Aloe Vera), Xylitol, Sodium Saccharin, Sucralose, Lauryl Glucoside, Cellulose Gum, Titanium Dioxide, Sodium Benzoate, Citric Acid.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    EARLY BIRD WINTERGREEN AND PEPPERMINT 
    potassium nitrate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72164-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72164-001-0196 g in 1 TUBE; Type 0: Not a Combination Product05/18/2018
    2NDC:72164-001-002 in 1 BOX05/18/201812/31/2019
    296 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/18/2018
    Labeler - Smiletwice, Inc. (117404286)
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