METADERM HYPER-MOISTURIZING DAILY CREAM- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis cream

Metaderm Hyper-Moisturizing Daily Cream by

Drug Labeling and Warnings

Metaderm Hyper-Moisturizing Daily 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

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:

Temporarily relieves the dryness, itching, flaking, rash, redness,
and skin irritation associated with with a wide variety of temporary and chronic
skin conditions.

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

Other ingredients:

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

INGREDIENTS AND APPEARANCE

METADERM HYPER-MOISTURIZING DAILY 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: 58133-350
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)
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)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-350-32	950 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2018
2	NDC: 58133-350-06	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(58133-350)