Label: COUPLING CHAMOMILE RELAX PREMIUM MASSAGELOTION- propanediol lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 13, 2022

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  • ACTIVE INGREDIENT

    PROPANEDIOL

  • INACTIVE INGREDIENT

    green tea extract, citric acid, etc.

  • PURPOSE

    skin protectant

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    apply proper amount to the skin and gently massage

  • WARNINGS

    For external use only.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COUPLING CHAMOMILE RELAX PREMIUM MASSAGELOTION 
    propanediol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74196-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPANEDIOL (UNII: 5965N8W85T) (PROPANEDIOL - UNII:5965N8W85T) PROPANEDIOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74196-0005-1120 g in 1 BOTTLE; Type 0: Not a Combination Product01/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/13/2022
    Labeler - ACE PHARMACEUTICAL CO LTD (689058677)
    Registrant - ACE PHARMACEUTICAL CO LTD (689058677)
    Establishment
    NameAddressID/FEIBusiness Operations
    ACE PHARMACEUTICAL CO LTD689058677manufacture(74196-0005)
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