Label: SKIN CARE- jojoba oil, chamomile extract, tea tree oil, aloe extract soap

  • 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 March 13, 2018

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  • Active ingredients

    Jojoba oil (0.9%)

    Chamomile Extract (0.9%)

    Tea tree oil (0.7%)

    Aloe Extract (0.7%)

  • Purpose

    Skin protectant

    Anti- itchy

    Anti-bacterial

    Humectant

  • Uses

    Moisturizes skin and helps to relieve skin irritation and itching for sensitive skin.

  • 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 of 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

    Sekken Soji, Alkoxy Glycerol, Grape Seed Oil, Tocophenol, Charcoal, Pure Water

  • Skin Care Soap

    skin care soap

  • INGREDIENTS AND APPEARANCE
    SKIN CARE 
    jojoba oil, chamomile extract, tea tree oil, aloe extract soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72100-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    JOJOBA OIL (UNII: 724GKU717M) (JOJOBA OIL - UNII:724GKU717M) JOJOBA OIL0.9 g  in 100 g
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE0.9 g  in 100 g
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE0.7 g  in 100 g
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72100-103-021 in 1 PACKAGE03/13/2018
    1NDC:72100-103-01100 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(72100-103)
    Establishment
    NameAddressID/FEIBusiness Operations
    Asan C&S631139649manufacture(72100-103)