Metaderm Scalp and Body: Homeopathic Product Information

METADERM SCALP AND BODY- matricaria chamomilla flowering top oil, sanguinaria canadensis root, achillea millefolium, berberis vulgaris fruit, conium maculatum fruit, rhus spp. whole, phytolacca octandra leaf and aesculus hippocastanum seed oil spray
Cosmetic Specialty Labs, Inc.

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.

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 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

DF32
(click image for full-size original)
PDP32
(click image for full-size original)

METADERM SCALP AND BODY
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:58133-380
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (MATRICARIA CHAMOMILLA FLOWERING TOP OIL) MATRICARIA CHAMOMILLA FLOWERING TOP OIL 5 [hp_M] in 1 mL
SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 8 [hp_M] in 1 mL
ACHILLEA MILLEFOLIUM (ACHILLEA MILLEFOLIUM) ACHILLEA MILLEFOLIUM 4 [hp_M] in 1 mL
BERBERIS VULGARIS FRUIT (BERBERIS VULGARIS FRUIT) BERBERIS VULGARIS FRUIT 9 [hp_M] in 1 mL
CONIUM MACULATUM FRUIT (CONIUM MACULATUM FRUIT) CONIUM MACULATUM FRUIT 21 [hp_M] in 1 mL
RHUS SPP. WHOLE (RHUS SPP. WHOLE) RHUS SPP. WHOLE 13 [hp_M] in 1 mL
PHYTOLACCA OCTANDRA LEAF (PHYTOLACCA OCTANDRA LEAF) PHYTOLACCA OCTANDRA LEAF 11 [hp_M] in 1 mL
AESCULUS HIPPOCASTANUM SEED OIL (AESCULUS HIPPOCASTANUM SEED OIL) AESCULUS HIPPOCASTANUM SEED OIL 4 [hp_M] in 1 mL
Inactive Ingredients
Ingredient Name Strength
VERONICA OFFICINALIS LEAF
ALTHAEA OFFICINALIS LEAF
SCROPHULARIA NODOSA
WATER
1-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)ETHANOL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
TUSSILAGO FARFARA
HYDRASTIS CANADENSIS WHOLE
SAMBUCUS NIGRA FLOWER OIL
MALVA SYLVESTRIS LEAF
POPULUS TREMULOIDES LEAF
POPULUS ALBA LEAF
COCHLEARIA OFFICINALIS LEAF
SARSAPARILLA
NASTURTIUM OFFICINALE
VINCETOXICUM ATRATUM ROOT
PIMPINELLA SAXIFRAGA ROOT
LENS CULINARIS FRUIT
AVENA SATIVA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58133-380-32 950 mL in 1 BOTTLE None
2 NDC:58133-380-04 118 mL in 1 BOTTLE, SPRAY None
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 Operations
Cosmetic Specialty Labs, Inc. 032973000 manufacture (58133-380)

Revised: 08/2018 Cosmetic Specialty Labs, Inc.

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