Metaderm Scalp and Body Spray

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:24

Label at a glance#

ProductMetaderm Scalp and Body
Active ingredientMATRICARIA CHAMOMILLA FLOWERING TOP OIL, SANGUINARIA CANADENSIS ROOT, ACHILLEA MILLEFOLIUM, BERBERIS VULGARIS FRUIT, CONIUM MACULATUM FRUIT, RHUS SPP. WHOLE, PHYTOLACCA OCTANDRA LEAF, AESCULUS HIPPOCASTANUM SEED OIL
Label structure9 sections

Indications and uses

Temporarily relieves the dryness, itching, flaking, rash, redness, and skin irritation associated with eczema, psoriasis, and dry skin.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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:

INDICATIONS & USAGE SECTION

Temporarily relieves the dryness, itching, flaking, rash, redness, and skin
irritation associated with eczema, psoriasis, and dry skin.

Warnings:

WARNINGS SECTION

for external use only

When using this product:

OTC - WHEN USING SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DF32DF32PDP32PDP32

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130793936986264GTIN-13: 0793936986264
EAN-13: 0793936986264
GTIN-12: 793936986264
UPC-A: 793936986264
GTIN storage (14 digits): 00793936986264
32oz scalp body spray-tp_Page_2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-380-042024-01-30C16284748780-11030e365-1d2a-111a-e063-dadaa90a10e2Metaderm Scalp and Body Spray
58133-380-322024-01-30C16284748780-11030e365-1d2a-111a-e063-dadaa90a10e2Metaderm Scalp and Body Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-380-04Metaderm Scalp and Body118 mL in 1 BOTTLE, SPRAYSPRAY1181
58133-380-32Metaderm Scalp and Body950 mL in 1 BOTTLESPRAY9501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-380METADERM SCALP AND BODY (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, BERBERIS VULGARIS, CONIUM MACULATUM, MATRICARIA CHAMOMILLA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS) SPRAY [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 2 package rows20180816_738ffed7-bec5-2861-e053-2991aa0a6d93.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-38058133-380-32, 58133-380-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
738fff2f-724e-642f-e053-2991aa0a1837738ffed7-bec5-2861-e053-2991aa0a6d932018-08-16WarningsExact identifier
spl id: 738fff2f-724e-642f-e053-2991aa0a1837
spl set id: 738ffed7-bec5-2861-e053-2991aa0a6d93

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.