Label: NATEAN CLEAN PLUS SENSITIVITY RELIEF- potassium nitrate, sodium fluoride paste

  • NDC Code(s): 0135-1250-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 1, 2021

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  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.15% w/v fluoride ion)

  • Purposes

    Antihypersensitivity

    Anticavity

  • Uses

    •
    builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    •
    aids in the prevention of dental cavities.
  • Warnings

    When using this product, if irritation occurs discontinue use.

    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.
    •
    pain/sensitivity still persists after 4 weeks of use.

    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 a 1-inch strip of the product onto a soft bristle toothbrush.
    •
    brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    •
    Children under 12 years of age: Consult a dentist or doctor.
  • Other information

    •
    do not store above 25°C (77F°)
  • Inactive ingredients

    water, hydrated silica, sorbitol, glycerin, flavor, cocamidopropyl betaine, sodium cocoyl glutamate, xanthan gum, rebaudioside A, cocos nucifera (coconut) oil, aloe barbadensis leaf extract, maltodextrin

  • Questions or comments?

    1-800-733-5879

  • Additional Information

    ALWAYS FOLLOW THE LABEL

    Natean was created by a small passionate team of scientists and herbalists on a mission to give you the best of what nature and science can offer, while minimizing our impact to the planet. Our toothpastes expertly balance powerful, scientifically studied ingredients with botanicals for a clean you can feel, and a clean you can feel good about.

    NATEAN-INSPIRED BY NATURE AND DESIGNED TO BE CLEAN

    RELIEVES SENSITIVE TEETH AND LEAVES YOUR MOUTH FEELING CLEAN AND FRESH

    •
    Infused with natural orange blossom and mint flavor, and extracts from aloe vera and coconut
    •
    Contains fluoride to fight cavities
    •
    Helps control tartar build-up with twice daily brushing

    *No animal origin materials used in the processing of these products. Contains no animal ingredients or derivatives.

    †Recycling facilities for this product may not exist in your area

    BPA-FREE TUBE

    Tube contains post consumer recycled plastic

    Recycleable carton, tube & cap

    Distributed by: Alacer Corp. Carlisle, PA 17013

    © 2021 Alacer Corp.

    www.nateantoothpaste.com

  • Principal Display Panel

    NDC 0135-1250-01

    Natean

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    NATURAL FLAVORS AND SWEETENERS

    NON-GMO / GLUTEN-FREE

    NO ARTIFICIAL PRESERVATIVES,

    COLORS, DYES

    NO SLS/TRICLOSAN

    VEGAN-FRIENDLY*

    INFUSED WITH

    BOTANICALS

    CLEAN + SENSITIVITY RELIEF

    SOOTHING MINT

    NET WT 4.7 OZ (133g)

    1001587 Front Carton

    Natean Clean+Sensitivity Relief 4.7 OZ
  • INGREDIENTS AND APPEARANCE
    NATEAN  CLEAN PLUS SENSITIVITY RELIEF
    potassium nitrate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-1250
    Route of AdministrationORAL
    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 ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Soothing Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-1250-011 in 1 CARTON01/03/2022
    1133 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 finalpart35601/03/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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