The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Metaderm Eczema Body And Scalp And Baby Body And Scalp (NDC 58133-390). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, when using this product:, stop use and ask a doctor if:, keep out of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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%)
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.
Temporarily protects and helps relieve minor skin irritation and
itching due to eczema.
for external use only
condition worsens or does not improve after
regular use as directed.
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.
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.
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.
* Please review the disclaimer below.
