Label: FIRST SALT AFTER RAIN GRAY SALT TOOTHPASTE- calcium carbonate paste, dentifrice

  • NDC Code(s): 83876-010-01, 83876-010-02
  • Packager: IMJACOMPANY.CO
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated January 11, 2024

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  • ACTIVE INGREDIENT

    CALCIUM CARBONATE 38.0%

  • Inactive ingredients

    Sorbitol, Water, Glycerin, Sodium Lauryl Sulfate, PEG-32, Cellulose Gum, Sodium Saccharin, Mentha Piperita Oil, Silica, Titanium Dioxide, Sodium Benzoate, Sodium Chloride, Dicalcium Phosphate Dihydrate, Menthol, 6-Aminocaproic Acid, Alcloxa, Xylitol, Ascorbic Acid

  • PURPOSE

    Anti-carries

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    helps protect against cavities.

  • Directions

    ■ adults and children 2 years of age and older : brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
    ■ children 2 to 6 years : use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
    ■ children under 2 years : ask a dentist or physician

  • Other Information

    Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

  • Questions

    https://firstsalt.kr
    +82 80-262-3800

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    FIRST SALT AFTER RAIN GRAY SALT TOOTHPASTE 
    calcium carbonate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83876-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION38.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83876-010-021 in 1 CARTON12/01/2023
    1NDC:83876-010-01120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2023
    Labeler - IMJACOMPANY.CO (695928991)
    Registrant - IMJACOMPANY.CO (695928991)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(83876-010)
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