Label: SHOPKINS BUBBLE GUM MOUTH WASH- sodium fluoride liquid

  • 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 January 11, 2017

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  • PURPOSE

    Anticavity

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Sodium Fluoride 0.5% (0.23% w/v fluoride ion) ......................... Anticavity

  • INDICATIONS & USAGE

    Helps protect teeth and roots against cavities

  • WARNINGS

    keep out of reach of children.

    If you accidentally swallow seek medical help or contact a poison control center immediately

  • INACTIVE INGREDIENT

    Water, Glycerine,PEG-40 Hydrogenated Castor Oil,Propylene Glycol,Xylitol,Benzyl Alcohol, Flavor, Sodium Benzoate, Sodium Saccharin, Zinc Gluconate, FD&C Red 40, D&C Red 33

  • DOSAGE & ADMINISTRATION

    Adults and children 6 years and older:
    Use daily after your normal brushing. Rinse toothpaste from your mouth prior to ouse.

    Rinse or gargle for 30 seconds with 15ml (3 teaspoonful) and then spit it out.

    Do not swallow the mouth wash

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    SHOPKINS BUBBLE GUM MOUTH WASH 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71106-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CITRAL PROPYLENE GLYCOL ACETAL (UNII: 9W7YHX7EX6)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL HYDROCHLORIDE, ERYTHRO-(+/-)- (UNII: 3IIJ9C722I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorred (FD & C Red 33) , red (FD &C Red 40) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71106-001-01479 g in 1 BOTTLE; Type 0: Not a Combination Product01/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/11/2017
    Labeler - Foshan Nanhai Jiachun Biology Engineering Co., Ltd (527935253)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Nanhai Jiachun Biology Engineering Co., Ltd527935253manufacture(71106-001)
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