UNITED AIRLINES PREMIUM PLUS 2019 - PURPLE WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ PRODUCTS (HK) CO. LIMITED]

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  • UNITED AIRLINES PREMIUM PLUS 2019 - PURPLE WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ PRODUCTS (HK) CO. LIMITED]

UNITED AIRLINES PREMIUM PLUS 2019 - PURPLE WITH COLGATE (SODIUM MONOFLUOROPHOSPHATE) KIT [BUZZ PRODUCTS (HK) CO. LIMITED]
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NDC 42555-060-94, 70402-026-01
Set ID c2da67fc-59bc-4218-abb6-1f4690a35322
Category HUMAN OTC DRUG LABEL
Packager Buzz Products (HK) Co. Limited
Generic Name
Product Class
Product Number
Application Number PART355
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  • Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

    Keep out of the 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 of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    children under 2 yearsask a dentist or physician

  • Inactive ingredients

    dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

  • Questions or comments?

    Call toll-free 1-800-468-6502

  • United Airlines Premium Plus Kit 2019 - Purple (70402-026-01)

    Kit2

  • COLGATE ANTICAVITY 5g (42555-060-94)

    COLGATE ANTICAVITY

  • Grey Ear Plugs

    Grey Ear Plugs

  • Package Labeling:

    Clear Plastic Toothbrush

  • INGREDIENTS AND APPEARANCE
    UNITED AIRLINES PREMIUM PLUS 2019 - PURPLE WITH COLGATE 
    sodium monofluorophosphate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70402-026
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70402-026-011 in 1 KIT04/01/201912/31/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 5 g
    Part 1 of 1
    COLGATE ANTICAVITY 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Item Code (Source)NDC:42555-060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42555-060-945 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/01/201912/31/2021
    Labeler - Buzz Products (HK) Co. Limited (663516515)
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