Label: GRAY SALT TOOTH- precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

  • NDC Code(s): 73242-0010-1
  • Packager: DONG IL PHARMS CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 15, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Precipitated Calcium Carbonate

    Dibasic Calcium Phosphate

    Aminocaproic Acid

    Aluminium Chlorohydroxy Allantoinate

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    A proper amount of toothpaste is put on the toothbrush and the tooth is cleaned by brushing.

  • WARNINGS

    Storage method

    1. Keep it at room temperature in a classified container.

    2. Cover and store at room temperature.

    3. Store in a not moisture and cool place.

    4. Air may come out during use of this product, but there is no problem with its weight.

    Usage Precautions

    1. Be careful not to swallow. Rinse mouth thoroughly after use

    2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

    3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

    4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

  • INACTIVE INGREDIENT

    Silicon Dioxide

    Xylitol

    L-Menthol

    Peppermint Oil

    Titanium Oxide

    Ascorbic Acid

    Water

    etc.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    GRAY SALT TOOTH 
    precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73242-0010
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE38 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.05 g  in 100 g
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS0.06 g  in 100 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73242-0010-1120 g in 1 TUBE; Type 0: Not a Combination Product07/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2019
    Labeler - DONG IL PHARMS CO.,LTD (557810721)
    Registrant - DONG IL PHARMS CO.,LTD (557810721)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(73242-0010)