METADERM 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.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Metaderm Hyper-Moisturizing Daily Cream

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:

Stop use and ask a doctor if:

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

DFPDP

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL5 [hp_M]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT8 [hp_M]  in 1 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM4 [hp_M]  in 1 mL
BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT9 [hp_M]  in 1 mL
CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K) (CONIUM MACULATUM FRUIT - UNII:Y71WKJ3A2K) CONIUM MACULATUM FRUIT21 [hp_M]  in 1 mL
RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE13 [hp_M]  in 1 mL
PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9) (PHYTOLACCA OCTANDRA LEAF - UNII:0804KD28Q9) PHYTOLACCA OCTANDRA LEAF11 [hp_M]  in 1 mL
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) (AESCULUS HIPPOCASTANUM SEED OIL - UNII:E0M52HIR1Y) AESCULUS HIPPOCASTANUM SEED OIL4 [hp_M]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-350-32950 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
2NDC:58133-350-06193 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/2018
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-350)

Revised: 8/2018
Document Id: 737e685a-0b31-de9a-e053-2a91aa0a6823
Set id: 737e685a-0b30-de9a-e053-2a91aa0a6823
Version: 1
Effective Time: 20180815
 
Cosmetic Specialty Labs, Inc.