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

Metaderm Psoriasis Body and Scalp by

Drug Labeling and Warnings

Metaderm Psoriasis Body and Scalp by is a Homeopathic medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

Fights recurrence of flaking, scaling, itching, redness, and skin
irritation associated with psoriasis

Warnings:

for external use only

Consult your doctor before using this product if the condition covers a
large area of the body

When using this product:

• Avoid contact with eyes.

Stop use and ask a doctor if:

condition worsens or does not improve after
regular use as directed.

Keep out of reach of children.

If swallowed, get medical help or
contact a Poison Control Center immediately. Test for allergy by
rubbing a small amount on skin first. Do not use if allergic to or
hypersensitive to any ingredient.

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.

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

INGREDIENTS AND APPEARANCE

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

Product 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)