METADERM SCALP AND BODY- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray 
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 Scalp and Body Spray

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

Psoriasis 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, psoriasis, and dry skin.

Warnings:

for external use only

When using this product:

Keep all medicines out of reach of children.

Directions:

Apply liberally at least twice daily, maximal results observed in
12 weeks. If using topical steroids, Metaderm can be added. If stopping
steroids, sudden withdrawal can result in flare, taper as necessary.

Other ingredients:

Purified Water, Hamamelis virginiana, Hydrastis
canadensis, Avena sativa, Populus tremuloides, Populas alba, Cochlearia
officinallis, Ervum lens, Veronica officinalis, Scrophularia nodosa, Sambucus
nigra, Althaea officinalis, Malva sylvestris, Tussilago farfara, Smilax medica,
Nasturtium officinale, Vincetoxicum officinale, Pimpinella saxifraga, Ethanol.

Principal Display Panel and Drug Facts

DF32PDP32

METADERM SCALP AND BODY 
achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-380
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
VERONICA OFFICINALIS LEAF (UNII: 96R87REA55)  
ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
WATER (UNII: 059QF0KO0R)  
1-(3,5-BIS(TRIFLUOROMETHYL)PHENYL)ETHANOL (UNII: 03H8X9K3I3)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D)  
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
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)  
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
AVENA SATIVA LEAF (UNII: 206PI19V7R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-380-32950 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
2NDC:58133-380-04118 mL in 1 BOTTLE, SPRAY; 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(58133-380)

Revised: 8/2018
Document Id: 738fff2f-724e-642f-e053-2991aa0a1837
Set id: 738ffed7-bec5-2861-e053-2991aa0a6d93
Version: 1
Effective Time: 20180816
 
Cosmetic Specialty Labs, Inc.