Metaderm Hyper-Moisturizing Daily 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 02:10:23

Label at a glance#

ProductMetaderm Hyper-Moisturizing Daily 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 with a wide variety of temporary and chronic skin conditions.

Dosage and administration

Apply 2 or more times daily for optimal relief, 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

Relieves temporary and chronic skin conditions

*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 with a wide variety of temporary and chronic
skin conditions.

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 2 or more times daily for optimal relief, or as needed.

Other ingredients:

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Stearic Acid, Cetyl
Alcohol, Carthamus tinctorius (Safflower) Seed Oil, Cocos Nucifera
(Coconut) Oil, Dimethicone, Glyceryl Stearate, Sodium PCA,
Niacinnamide, Phenoxyethanol, Caprylyl Glycol, Petrolatum,
Triethanolamine, 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

DFDFPDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-350-062024-01-30C16284748780-11030e365-54f9-111a-e063-dadaa90a10e2Metaderm Hyper-Moisturizing Daily Cream
58133-350-322024-01-30C16284748780-11030e365-54f9-111a-e063-dadaa90a10e2Metaderm Hyper-Moisturizing Daily Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-350-06Metaderm Hyper-Moisturizing Daily Cream193 mL in 1 BOTTLECREAM1931
58133-350-32Metaderm Hyper-Moisturizing Daily Cream950 mL in 1 BOTTLECREAM9501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-350METADERM HYPER-MOISTURIZING DAILY CREAM (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, BERBERIS VULGARIS, CONIUM MACULATUM, MATRICARIA CHAMOMILLA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 2 package rows20180816_737e685a-0b30-de9a-e053-2a91aa0a6823.zip

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-35058133-350-32, 58133-350-06

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 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
737e685a-0b31-de9a-e053-2a91aa0a6823737e685a-0b30-de9a-e053-2a91aa0a68232018-08-15WarningsExact identifier
spl id: 737e685a-0b31-de9a-e053-2a91aa0a6823
spl set id: 737e685a-0b30-de9a-e053-2a91aa0a6823

Reported adverse events (FAERS/openFDA)#

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