Label: METADERM SCALP AND BODY- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-380-04, 58133-380-32 - Packager: Cosmetic Specialty Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
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
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- Official Label (Printer Friendly)
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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
- Uses:
- Warnings:
- When using this product:
- KEEP OUT OF REACH OF CHILDREN
- Directions:
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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
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INGREDIENTS AND APPEARANCE
METADERM SCALP AND BODY
achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-380 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL 5 [hp_M] in 1 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 8 [hp_M] in 1 mL ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM 4 [hp_M] in 1 mL BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT 9 [hp_M] in 1 mL CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K) (CONIUM MACULATUM FRUIT - UNII:Y71WKJ3A2K) CONIUM MACULATUM FRUIT 21 [hp_M] in 1 mL RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE 13 [hp_M] in 1 mL PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9) (PHYTOLACCA OCTANDRA LEAF - UNII:0804KD28Q9) PHYTOLACCA OCTANDRA LEAF 11 [hp_M] in 1 mL AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) (AESCULUS HIPPOCASTANUM SEED OIL - UNII:E0M52HIR1Y) AESCULUS HIPPOCASTANUM SEED OIL 4 [hp_M] in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-380-32 950 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2018 2 NDC:58133-380-04 118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 08/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/15/2018 Labeler - Cosmetic Specialty Labs, Inc. (032973000) Registrant - Cosmetic Specialty Labs, Inc. (032973000) Establishment Name Address ID/FEI Business Operations Cosmetic Specialty Labs, Inc. 032973000 manufacture(58133-380)