Metaderm Excema Body and Scalp Spray Metaderm Excema Baby Body and Scalp 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 Eczema Body and Scalp and Baby Body and Scalp
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 structure10 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

Dosage and administration

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.

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

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:

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and
itching due to eczema.

Warnings:

WARNINGS SECTION

for external use only

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP4PDP4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-390-04Metaderm Eczema Body and Scalp and Baby Body and Scalp118 mL in 1 BOTTLE, SPRAYSPRAY1181
58133-390-32Metaderm Eczema Body and Scalp and Baby Body and Scalp950 mL in 1 BOTTLESPRAY9501
58133-390-33Metaderm Eczema Body and Scalp and Baby Body and Scalp950 mL in 1 BOTTLESPRAY9501
58133-390-40Metaderm Eczema Body and Scalp and Baby Body and Scalp118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-390METADERM ECZEMA BODY AND SCALP AND BABY BODY AND SCALP (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, BERBERIS VULGARIS, CONIUM MACULATUM, MATRICARIA CHAMOMILLA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS) SPRAY [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 4 package rows20180817_7393a857-80cb-64ba-e053-2991aa0a2104.zip

Products#

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

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-39058133-390-32, 58133-390-04, 58133-390-33, 58133-390-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Source Document#

Source XML · Source PDF

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
7393a857-80cc-64ba-e053-2991aa0a21047393a857-80cb-64ba-e053-2991aa0a21042018-08-16WarningsExact identifier
spl id: 7393a857-80cc-64ba-e053-2991aa0a2104
spl set id: 7393a857-80cb-64ba-e053-2991aa0a2104

Reported adverse events (FAERS/openFDA)#

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