Label: HEY HUMANS WHITENING CLEAN MINT RUSH- sodium fluoride 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 March 1, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

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

  • Purpose

    Anticavity

  • Uses

    • Helps protect against cavities.
  • Warnings

    • Keep out of reach of children under 6 years of age.
    • If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Adults and children 2 years and older:
      • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    • Children 2 to 6 years:
      • To minimize swallowing, use only a pea-sized amount.
      • Supervise children's brushing and rinsing until good habits are established.
    • Children under 2 years of age: Consult a dentist or physician.
  • Inactive Ingredients

    Glycerin, Sorbitol, Hydrated Silica, Water, Xylitol, Cocamidopropyl Betaine, Flavor, Sodium Cocoyl Glutamate, Xanthan Gum, Stevia Rebaudiana Leaf/Stem Extract, Cellulose Gum, Menthol, Squalene.

  • Questions or Comments

    You may report an adverse reaction to: HEY HUMANS c/o Report Reaction LLC, PO Box 22, Plainsboro, NJ 08536-0222.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: MAESA LLC
    225 LIBERTY STREET,
    NEW YORK, NY 10281.

  • PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

    Naturally Derived
    Toothpaste

    With Fluoride

    Hey
    Humans

    With Everice™
    Technology

    WHITENING

    Long-lasting fresh breath,
    anticavity, anti-plaque,
    anti-tartar

    Clean Mint
    Rush

    Artificial sweetener,
    phthalate, paraben
    & sulfate free

    NET WT. 96 g / 3.4 OZ.

    PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    HEY HUMANS WHITENING CLEAN MINT RUSH 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71899-200
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Sodium Cocoyl Glutamate (UNII: BMT4RCZ3HG)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Stevia Rebaudiuna Leaf (UNII: 6TC6NN0876)  
    Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Squalene (UNII: 7QWM220FJH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71899-200-011 in 1 CARTON01/31/2021
    196 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/31/2021
    Labeler - Maesa LLC (144282311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutrix International LLC117341868MANUFACTURE(71899-200)
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