Label: IPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active Ingredients

    Sodium Monofluorophosphate 0.76% (Fluoride 0.1% w/w)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • Warnings

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

    If more than used for brushing is accidentaly swallowed get medical help or contact a Poison Control Center right away. external use only.

  • Directions

    • Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or doctor.
    • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
    • Children under 2 years: Consult a dentist or doctor.
  • Inactive Ingredients

    dicalcium phpsphate dihydrate, water, glycerin, hydrated silica, sorbitol, carboxymethylcellulose, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, sodium benzoate

  • Product Label

    ipana

    presents

    Bucky Beaver

    Bubble Gum

    Children's Fluoride Toothpaste

    NET WT. 0.66 OZ (19g)

    ITEM 40510

    Dist. by:

    Maxill inc.

    Cortland, OH, USA  44410

    1-800-268-8633 www.maxill.com

    Made in Malaysia

    bubblegumlabel

  • INGREDIENTS AND APPEARANCE
    IPANA BUCKY BEAVER BUBBLE GUM CHILDRENS FLUORIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69510-020
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69510-020-191 in 1 BOX01/05/2015
    119 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/31/2014
    Labeler - Maxill Inc (079343581)
    Establishment
    NameAddressID/FEIBusiness Operations
    AmLion Toothpaste Sdn. Bhd652244161manufacture(69510-020)
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