Label: UP TOOTHPASTE,LEMON CITRON- sodium fluoride toothpaste paste, dentifrice
DOWN TOOTHPASTE,GINGERSNAP- sodium fluoride toothpaste paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 21, 2022

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  • Active ingredients

    Sodium fluoride 0.24%

  • Purpose

    Anticavity

  • Uses

    aids in the prevention of dental cavities.

  • Warnings

    If more than used for brushing is accidentally swallowed, get medical help or

    contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years of age.

  • Directions

    1 Wet toothbrush and apply a generous amount of your Whole Body Toothpaste

    2 Brush thoroughly for 2 minutes.

    3 Rinse and spit out paste after brushing.

    4 Do not swallow.

  • Inactive ingredients

    Inactive ingredients (up): Sorbitol, glycerin, xylitol, water, hydrated silica, chamomile, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, sodium bicarbonate, lemon balm, titanium dioxide, stevia, sodium fluoride, benzoic acid, melatonin, L-Theanine

    Inactive ingredients (down): sorbitol, glycerin, xylitol, hydrated silica, water, anthemis nobilis (chamomile), sodium bicarbonate, sodium carboxymethylcellulose, sodium methyl cocoyl taurate, lemon balm extract, titanium dioxide, stevia, benzoic acid, melatonin, l-theanine, nutmeg, ginger root, cinnamomum zeylanicum (cinnamon) oil

  • Attention

    Twist off cap to remove foil seal

    Do not use if the safety seal is missing or broken

    This product contains caffeine, which could be something to avoid if you are sensitive

    For human use only

  • Need help with anything?

    We want to help!

    Talk to a human: +1 714 363 3599

    Write to us: support@taoclean.com

    Distributed by TAO Clean® LLC. Orange, CA 92866

    Proudly made in the USA

    UP TOOTHPASTE, LEMON CITRON, 60 ML 81301-0512-01 • DOWN TOOTHPASTE, GINGERSNAP, 60 ML 81301-0513-01

    20352 • BA-0511-IM

  • PRINCIPAL DISPLAY PANEL

    Panel 1Panel 2

  • INGREDIENTS AND APPEARANCE
    UP TOOTHPASTE,LEMON CITRON 
    sodium fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81301-0512
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STEVIA LEAF (UNII: 6TC6NN0876)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    PYRIDOXINE (UNII: KV2JZ1BI6Z)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    THEANINE (UNII: 8021PR16QO)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAFFEINE (UNII: 3G6A5W338E)  
    METHYLCOBALAMIN (UNII: BR1SN1JS2W)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81301-0512-21 in 1 BOX08/16/2021
    1NDC:81301-0512-168.57 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/16/2021
    DOWN TOOTHPASTE,GINGERSNAP 
    sodium fluoride toothpaste paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81301-0513
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    STEVIA LEAF (UNII: 6TC6NN0876)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    THEANINE (UNII: 8021PR16QO)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GINGER (UNII: C5529G5JPQ)  
    NUTMEG (UNII: AEE24M3MQ9)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MELATONIN (UNII: JL5DK93RCL)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGINGER, CINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81301-0513-21 in 1 BOX08/16/2021
    1NDC:81301-0513-168.57 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/16/2021
    Labeler - TAO CLEAN, LLC (079587463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Massco Dental008081858manufacture(81301-0512, 81301-0513)
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