Label: UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE- sodium fluoride paste

  • NDC Code(s): 52000-110-01
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 16, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sodium Fluoride-0.32% (0.15% w/v fluride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Uses

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

    Warning

  • WHEN USING

    When using this product

    • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
  • STOP USE

    Stop and ask a dentist

    • if the problem persists or worsens.

    Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If accidentally swallowed while brushing, seek professional help or contact a Poison Control Center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older
    • apply atleast 1-inch strip of product onto soft bristle toothbrush
    • brush teeth thoroughly for atleast 1 minute twice a day (morning and evening), and not more then 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

  • SPL UNCLASSIFIED SECTION

    Other information

    • store in a cool, dry place.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Sorbitol, Silica, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium Lauryl sulphate, Water, Flavor, Charcoal powder, poly ethylene glycol 1500, Aloe vera.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE TOOTHPASTE

    label

  • INGREDIENTS AND APPEARANCE
    UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-110
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-110-01122 g in 1 TUBE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/25/2020
    Labeler - Universal Distribution Center LLC (019180459)
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