Label: POP GEL PUMPIN STRAWBERRY- 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 September 18, 2023

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  • Drug Facts

    Drug Facts

  • Active Ingredient

    SODIUM FLUORIDE 0.243% (0.13% w/v fluoride ion)

  • Purpose

    Anticavity toopaste

  • Use

    helps protect against cavities

  • Warnings

    Warnings

    Keep out of reach of children.

    Keep out of reach of children under 6 years of age. Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

  • Directions

    • adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
    • ​do not swallow.
    • ​to minimize swallowing use a pea-sized amount in children under 6.
    • ​supervise children's brushing until good habits are established.
    • ​ children under 2 years: ask a dentist.
  • Inactive Ingredients

    GLYCERIN, WATER, HYDRATED SILICA, SODIUM LAURYL SULFATE, FLAVOR, XANTHAN GUM, TETRASODIUM PYROPHOSPHATE, POLOXAMER 407, SODIUM POLYACRYLATE, ZINC STEARATE, SODIUM SACCHARIN, SORBITAN OLEATE, TITANIUM DIOXIDE, SUCRALOSE, HYDROXYAPATITE, NIACINAMIDE, TOCOPHERYL ACETATE, XYLITOL

  • Questions?

    1-866-993-4709

  • Principal Display Panel - 160 g Tube Carton

    POP

    Playful. Original. Personal.

    GEL TOOTHPASTE
    Electric Toothbrush Suitable

    3X faster fluoride release*
    Repairs & protects enamel

    NET WT. 5.64 OZ. (160 G)

    Pumpin' Strawberry

    DISTR. LG H&H CO., LTD.

    58, SAEMUNAN-RO, JONGNO-GU,
    SEOUL, KOREA
    www.oralcarebypop.com

    MADE IN KOREA

    *Compared to tube toothpaste,
    when used with an electric
    toothbrush.

    POP_Gel_Pumpkin_Strawberry_160g_IC

  • INGREDIENTS AND APPEARANCE
    POP GEL PUMPIN STRAWBERRY 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-581
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    WATER (UNII: 059QF0KO0R)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Strawberry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-581-601 in 1 CARTON09/18/2023
    1160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/18/2023
    Labeler - LG H&H CO., LTD. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(53208-581)
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