Label: COUPLING CHAMOMILE RELAX PREMIUM MASSAGELOTION- propanediol lotion

  • NDC Code(s): 74196-0005-1
  • Packager: ACE PHARMACEUTICAL 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 January 13, 2022

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

  • 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)