FDA.reportPublic FDA data

Metaderm Eczema and Baby Eczema Cream

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2018-08-15
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 and Baby Eczema Cream
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 relieves the dryness, itching, flaking, rash, redness, and skin irritation associated with eczema.

Dosage and administration

Apply to affected area 2 times daily or as needed.

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

Eczema 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.

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.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to affected area 2 times daily or as needed.

Other ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Aloe Barbadensis Leaf Juice,
Stearic Acid, Carthamus tinctorius (Safflower) Seed Oil, Dimethicone,
Glyceryl Stearate, Cetyl Alcohol, Niacinamide, Sodium PCA,
Phenoxyethanol, Petrolatum, Triethanolamine, Caprylyl Glycol,
Carbomer, Tocopheryl Acetate, Hamamelis virginiana, Hydrastis
canadensis, Avena sativa, Populus tremuloides, Populus alba,
Cochlearia officinalis, Ervum lens, Veronica officinalis, Scrophularia
nodosa, Sambucus nigra, Althaea officinalis, Malva sylvestris,
Tussilago farfara, Smilax medica, Nasturtium officinale,
Vincetoxicum officinale, Pimpinella saxifraga.

Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DF2DF2PDP2PDP2DF1DF1PDP1PDP1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-360-062024-01-30C16284748780-11030e365-3c84-111a-e063-dadaa90a10e2Metaderm Eczema Cream Metaderm Baby Eczema Lotion
58133-360-322024-01-30C16284748780-11030e365-3c84-111a-e063-dadaa90a10e2Metaderm Eczema Cream Metaderm Baby Eczema Lotion
58133-360-652024-01-30C16284748780-11030e365-3c84-111a-e063-dadaa90a10e2Metaderm Eczema Cream Metaderm Baby Eczema Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-360-06Metaderm Eczema and Baby Eczema Cream193 mL in 1 BOTTLECREAM1931
58133-360-32Metaderm Eczema and Baby Eczema Cream950 mL in 1 BOTTLECREAM9501
58133-360-65Metaderm Eczema and Baby Eczema Cream193 mL in 1 BOTTLECREAM1931

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-360METADERM ECZEMA AND BABY ECZEMA CREAM (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, BERBERIS VULGARIS, CONIUM MACULATUM, MATRICARIA CHAMOMILLA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 3 package rows20180816_737efd41-2d57-6013-e053-2a91aa0a6c63.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-36058133-360-32, 58133-360-06, 58133-360-65

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
VERONICA OFFICINALIS LEAF96R87REA55IACT
ALTHAEA OFFICINALIS LEAFE2QQV92338IACT
SCROPHULARIA NODOSA7H443NUB2TIACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
BERBERIS VULGARIS FRUIT6XEF22AHC3ACTIB
CONIUM MACULATUM FRUITY71WKJ3A2KACTIB
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHANOLAMINE LAURYLAMINOPROPIONATE793J74ICPWIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER 9404Q93RCW27EIACT
DIMETHICONE92RU3N3Y1OIACT
HYDRASTIS CANADENSIS WHOLER763EBH88TIACT
LENS CULINARIS FRUITZYZ076G9JHIACT
SAMBUCUS NIGRA FLOWER OILQ35633V53DIACT
MALVA SYLVESTRIS LEAF17H39B00T5IACT
TUSSILAGO FARFARA0JXZ63016VIACT
RHUS SPP. WHOLE3U7FG9T9MWACTIB
PHYTOLACCA OCTANDRA LEAF0804KD28Q9ACTIB
STEARIC ACID4ELV7Z65APIACT
NIACINAMIDE25X51I8RD4IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
AVENA SATIVA LEAF206PI19V7RIACT
POPULUS TREMULOIDES LEAF7IIH57D9E0IACT
POPULUS ALBA LEAFA74CT64437IACT
COCHLEARIA OFFICINALIS LEAFWAG1VW36J6IACT
AESCULUS HIPPOCASTANUM SEED OILE0M52HIR1YACTIB
SARSAPARILLA2H1576D5WGIACT
NASTURTIUM OFFICINALEYH89GMV676IACT
VINCETOXICUM ATRATUM ROOT7DQZ24B35YIACT
PIMPINELLA SAXIFRAGA ROOT5Y05905N7GIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PETROLATUM4T6H12BN9UIACT

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
737efd41-2d58-6013-e053-2a91aa0a6c63737efd41-2d57-6013-e053-2a91aa0a6c632018-08-15WarningsExact identifier
spl id: 737efd41-2d58-6013-e053-2a91aa0a6c63
spl set id: 737efd41-2d57-6013-e053-2a91aa0a6c63

Reported adverse events (FAERS/openFDA)#

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