Label: METADERM ECZEMA AND BABY ECZEMA CREAM- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis cream

  • 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 15, 2018

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  • 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

    Eczema 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.

  • 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.
  • Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation develops
  • KEEP OUT OF REACH OF CHILDREN

    Keep all medicines out of reach of children.

  • Directions:

    Apply to affected area 2 times daily or as needed.

  • Other ingredients:

    Purified Water, Aloe Barbadensis Leaf Juice,
    Stearic Acid, Carthamus tinctorius (Safflower) Seed Oil, Dimethicone,
    Glyceryl Stearate, Cetyl Alcohol, Niacinamide, Sodium PCA,
    Phenoxyethanol, Petrolatum, Triethanolamine, Caprylyl Glycol,
    Carbomer, Tocopheryl Acetate, Hamamelis virginiana, Hydrastis
    canadensis, Avena sativa, Populus tremuloides, Populus alba,
    Cochlearia officinalis, Ervum lens, Veronica officinalis, Scrophularia
    nodosa, Sambucus nigra, Althaea officinalis, Malva sylvestris,
    Tussilago farfara, Smilax medica, Nasturtium officinale,
    Vincetoxicum officinale, Pimpinella saxifraga.

  • Principal Display Panel and Drug Facts

    DF2PDP2DF1PDP1

  • INGREDIENTS AND APPEARANCE
    METADERM ECZEMA AND BABY ECZEMA CREAM 
    achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-360
    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
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    VERONICA OFFICINALIS LEAF (UNII: 96R87REA55)  
    ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D)  
    MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
    TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    AVENA SATIVA LEAF (UNII: 206PI19V7R)  
    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)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-360-32950 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
    2NDC:58133-360-06193 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
    3NDC:58133-360-65193 mL in 1 BOTTLE; 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(58133-360)
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