Label: ECZEMA THERAPY- chamomile extract, tea tree oil, aloe extract soap

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

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Drug Label Information

Updated March 13, 2018

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  • Active ingredients

    Chamomile Extract (0.3%)

    Tea tree oil (0.2%)

    Aloe Extract (0.12%)

  • Purpose

    Anti-itchy

    Anti-bacterial

    Humectant

  • Uses

    Helps to relieve skin irritation and itching due to eczema.

  • Warnings

    For external use only

    Do not use when skin is red, inflamed, irritated, or painful

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    • do not apply directly to wound or open cut

    Stop use and ask a doctor if

    • rash or irritation on skin develops and lasts
    • condition does not improve or worsen after regular use of this product as directed
  • Keep out reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    1. Wet soap to generate foam to cover desired part of face or body

    2. Massage foam well into the skin rubbing gently.

    3. Rinse after 3-5 min.

    4. Pat dry with soft cloth, leaving bit of moisture.

    5. Repeat 2-3 times daily as needed.

  • Inactive ingredients

    Peanut Oil, Zinc Oxide, Shea Butter, Arginine, Grape Seed Oil, Gardenia Seed Extract, Green Tea Extract, Mugwort Extract, Licorice Root Extract, Shrubby Sophora Extract, Tocophenol, Pure Water, charcoal, Sekken Soji

  • Eczema Therapy Soap

    eczema soap

  • INGREDIENTS AND APPEARANCE
    ECZEMA THERAPY 
    chamomile extract, tea tree oil, aloe extract soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72100-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE0.3 g  in 100 g
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.2 g  in 100 g
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    LICORICE (UNII: 61ZBX54883)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    ARGININE (UNII: 94ZLA3W45F)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    PEANUT OIL (UNII: 5TL50QU0W4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72100-101-021 in 1 PACKAGE03/13/2018
    1NDC:72100-101-01100 g in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/13/2018
    Labeler - Golden B America, LLC. (081015296)
    Registrant - Golden B America, LLC. (081015296)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden B America, LLC.081015296relabel(72100-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Asan C&S631139649manufacture(72100-101)
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