Label: METADERM SCALP AND BODY- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 16, 2018

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

  • Active Ingredient

    Achillea millefolium (3X H.P.U.S.*, 0.04%)
    Aesculus hippocastanum (3X H.P.U.S.*, 0.04%)
    Berberis vulgaris (3X H.P.U.S.*, 0.09%)
    Conium maculatum (3X H.P.U.S.*, 0.21%)
    Matricaria chamomilla (3X H.P.U.S.*, 0.05%)
    Phytolacca decandra (3X H.P.U.S.*, 0.11%)
    Rhus toxicodendron (3X H.P.U.S.*, 0.13%)
    Sanguinaria canadensis (3X H.P.U.S.*, 0.08%)

  • Purpose

    Psoriasis relief

    *The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • Uses:

    Temporarily relieves the dryness, itching, flaking, rash, redness, and skin
    irritation associated with eczema, psoriasis, and dry skin.

  • Warnings:

    for external use only

  • When using this product:

    • Avoid contact with eyes.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
    • Test for allergy by rubbing small amount on skin first.
    • Do not use if allergic to or hypersensitive to any ingredient.
    • If condition worsens or does not improve consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep all medicines out of reach of children.

  • Directions:

    Apply liberally at least twice daily, maximal results observed in
    12 weeks. If using topical steroids, Metaderm can be added. If stopping
    steroids, sudden withdrawal can result in flare, taper as necessary.

  • Other ingredients:

    Purified Water, Hamamelis virginiana, Hydrastis
    canadensis, Avena sativa, Populus tremuloides, Populas alba, Cochlearia
    officinallis, Ervum lens, Veronica officinalis, Scrophularia nodosa, Sambucus
    nigra, Althaea officinalis, Malva sylvestris, Tussilago farfara, Smilax medica,
    Nasturtium officinale, Vincetoxicum officinale, Pimpinella saxifraga, Ethanol.

  • Principal Display Panel and Drug Facts

    DF32PDP32

  • INGREDIENTS AND APPEARANCE
    METADERM SCALP AND BODY 
    achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-380
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL5 [hp_M]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT8 [hp_M]  in 1 mL
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM4 [hp_M]  in 1 mL
    BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT9 [hp_M]  in 1 mL
    CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K) (CONIUM MACULATUM FRUIT - UNII:Y71WKJ3A2K) CONIUM MACULATUM FRUIT21 [hp_M]  in 1 mL
    RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE13 [hp_M]  in 1 mL
    PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9) (PHYTOLACCA OCTANDRA LEAF - UNII:0804KD28Q9) PHYTOLACCA OCTANDRA LEAF11 [hp_M]  in 1 mL
    AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) (AESCULUS HIPPOCASTANUM SEED OIL - UNII:E0M52HIR1Y) AESCULUS HIPPOCASTANUM SEED OIL4 [hp_M]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    VERONICA OFFICINALIS LEAF (UNII: 96R87REA55)  
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    WATER (UNII: 059QF0KO0R)  
    1-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)ETHANOL (UNII: 03H8X9K3I3)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0)  
    POPULUS ALBA LEAF (UNII: A74CT64437)  
    COCHLEARIA OFFICINALIS LEAF (UNII: WAG1VW36J6)  
    SARSAPARILLA (UNII: 2H1576D5WG)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    VINCETOXICUM ATRATUM ROOT (UNII: 7DQZ24B35Y)  
    PIMPINELLA SAXIFRAGA ROOT (UNII: 5Y05905N7G)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-380-32950 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
    2NDC:58133-380-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/15/2018
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-380)