METADERM ECZEMA AND BABY ECZEMA CREAM- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis cream

Metaderm Eczema and Baby Eczema Cream by

Drug Labeling and Warnings

Metaderm Eczema and Baby Eczema Cream by is a Homeopathic medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

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:

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

Warnings:

for external use only

When using this product:

• 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:

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

KEEP OUT OF REACH OF CHILDREN

Keep all medicines out of reach of children.

Directions:

Apply to affected area 2 times daily or as needed.

Other ingredients:

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

INGREDIENTS AND APPEARANCE

METADERM ECZEMA AND BABY ECZEMA CREAM 
achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER)	MATRICARIA CHAMOMILLA FLOWERING TOP OIL	5 [hp_M]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	8 [hp_M]  in 1 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	4 [hp_M]  in 1 mL
BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3)	BERBERIS VULGARIS FRUIT	9 [hp_M]  in 1 mL
CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K) (CONIUM MACULATUM FRUIT - UNII:Y71WKJ3A2K)	CONIUM MACULATUM FRUIT	21 [hp_M]  in 1 mL
RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW)	RHUS SPP. WHOLE	13 [hp_M]  in 1 mL
PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9) (PHYTOLACCA OCTANDRA LEAF - UNII:0804KD28Q9)	PHYTOLACCA OCTANDRA LEAF	11 [hp_M]  in 1 mL
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) (AESCULUS HIPPOCASTANUM SEED OIL - UNII:E0M52HIR1Y)	AESCULUS HIPPOCASTANUM SEED OIL	4 [hp_M]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
VERONICA OFFICINALIS LEAF (UNII: 96R87REA55)
ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)
SCROPHULARIA NODOSA (UNII: 7H443NUB2T)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 940 (UNII: 4Q93RCW27E)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D)
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)
TUSSILAGO FARFARA (UNII: 0JXZ63016V)
STEARIC ACID (UNII: 4ELV7Z65AP)
NIACINAMIDE (UNII: 25X51I8RD4)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
AVENA SATIVA LEAF (UNII: 206PI19V7R)
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0)
POPULUS ALBA LEAF (UNII: A74CT64437)
COCHLEARIA OFFICINALIS LEAF (UNII: WAG1VW36J6)
SARSAPARILLA (UNII: 2H1576D5WG)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
VINCETOXICUM ATRATUM ROOT (UNII: 7DQZ24B35Y)
PIMPINELLA SAXIFRAGA ROOT (UNII: 5Y05905N7G)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-360-32	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2018
2	NDC: 58133-360-06	193 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2018
3	NDC: 58133-360-65	193 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/2018

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-360)