Label: METADERM PSORIASIS BODY AND SCALP- 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): 58133-391-04, 58133-391-32 - Packager: Cosmetic Specialty Labs, Inc.
- 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.
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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
Cracking, Dryness, Rash, Scaling
Inflammation, itching
Burning, Itching, Redness, Scaling
Burning, Itching, Inflammation
Redness, Itching
Inflammation, Itching, Redness
Bleeding, Redness
Dryness, Irritation, Itching*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:
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Keep out of reach of children.
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Directions:
For scalp, part hair, hold targeted nozzle no more than 1 inch from scalp, and spray at the roots to cover the affected area. For body, hold nozzle about 6 inches from skin and spray to cover the affected area. Lightly massage into scalp or skin with fingertips, No rinsing. Repeat on all affected areas and style hair as usual. Apply liberally to dry or wet skin 2 times daily.
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Other ingredients:
Purified Water, Glycerin, Niacinamide, Phenoxyethanol,
1,2-Hexanediol, Caprylyl Glycol, Acrylates-C10-30 Alkyl
Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Citrate,
Polysorbate-20, Citric Acid, Hamamelis virginiana, Hydrastis canadensis,
Avena sativa, Populus alba, Populus tremuloides, Cochlearia ocinalis,
Ervum lens, Scrophularia nodosa, Veronica ocinalis, Althaea ocinalis,
Sambucus nigra, Malva sylvestris, Nasturtium ocinale, Smilax medica,
Tussilago farfara, Pimpinella saxifraga, Vincetoxicum ocinale.
- Principal Display Panel and Drug Facts
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INGREDIENTS AND APPEARANCE
METADERM PSORIASIS BODY AND SCALP
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:58133-391 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 110 [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 1,2-HEXANEDIOL (UNII: TR046Y3K1G) POLYSORBATE 20 (UNII: 7T1F30V5YH) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) VERONICA OFFICINALIS LEAF (UNII: 96R87REA55) ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338) SCROPHULARIA NODOSA (UNII: 7H443NUB2T) WATER (UNII: 059QF0KO0R) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) TUSSILAGO FARFARA (UNII: 0JXZ63016V) LENS CULINARIS FRUIT (UNII: ZYZ076G9JH) SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D) MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5) NIACINAMIDE (UNII: 25X51I8RD4) 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) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) SODIUM CITRATE (UNII: 1Q73Q2JULR) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-391-32 950 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/15/2018 2 NDC:58133-391-04 118 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(58133-391)
