Label: AI KUNGANG- calcium carbonate liquid

  • 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 January 2, 2023

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  • ACTIVE INGREDIENT

    calcium carbonate

  • INACTIVE INGREDIENT

    Carboxymethyl cellulose sodium salt, guargum, water

  • PURPOSE

    40% reduction in radon
    TVOC reduction
    Reduction of formaldehyde
    Toluene reduction
    More than 99% antibacterial
    More than 80% of deodorization
    Moisture absorption/moisture proof
    No heavy metal detection
    Firefighting: Semi-incombustible
    Radiation of 90.2% of far-infrared rays

  • WARNINGS

    ■ if following abnormal symptoms persist, discontinue use

    Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

    ■ Stop immediately and consult a doctor if you experience

    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.

    2) Skin Irritation

    3) Following Instructions when using medication

    (1) For external use only (Do not use internally)

    (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)

    ■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.

    ■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

    It is not recommended to use this one areas that have been medically treated with a cast or bandage.

    ■ Do not use in combination with soap or antibacterial cleansing agents.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep Out of Reach of Children.

  • INDICATIONS & USAGE

    ■ apply proper amount to the skin

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AI KUNGANG 
    calcium carbonate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81768-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE55 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81768-0001-12000 mL in 1 CAN; Type 0: Not a Combination Product04/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/14/2021
    Labeler - TheJoenSpace Co,. LTD (695644078)
    Registrant - TheJoenSpace Co,. LTD (695644078)
    Establishment
    NameAddressID/FEIBusiness Operations
    TheJoenSpace Co,. LTD695644078manufacture(81768-0001)