Label: ECZEMA AND PSORIASIS FREE- sambucus nigra flower, calendula officinalis flower, echinacea angustifolia, berberis vulgaris whole salve

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated February 26, 2014

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    PINUS SILVESTRIS (1X) HPUS (PINE RESIN)

    *SAMBUCUS NIGRA (2X) HPUS (ELDERBERRY)

    *CALENDULA OFFICINALIS (2X) HPUS (MARIGOLD)

    *BERBERIS AQUIFOLIUM (3X) HPUS (BARBERRY)

    *ECHINACEA ANGUST. (6X) HPUS (ECHINACEA)

  • PURPOSE

    PROPERTIES

    SKIN PROTECTANT

    ANTI-INFLAMMATORY

    PROMOTES SKIN HEALING

    ECZEMA AND PSORIASIS TREATMENT

    PROMOTES SKIN HEALING

  • INDICATIONS & USAGE

    USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH ECZEMA, PSORIASIS, DERMATITIS, SEVERE DRY ITCHY SKIN.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: APPLY TO AFFECTED AREA 3-4 TIMES PER DAY.

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: ORGANIC OLIVE OIL, HIGH OLEIC SAFFLOWER OIL, ORGANIC BEESWAX, BALSAM FIR, ORGANIC SOY FREE VITAMIN E OIL.

  • WARNINGS

    WARNING: TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN FIRST. DO NOT USE IF ALLERGIC TO OR HYPER-SENSITIVE TO ANY INGREDIENT IN THIS SALVE. IF CONDITION PERSISTS OR WORSENS CONSULT YOUR HEALTH CARE PROVIDER. (* CERTIFIED ORGANIC INGREDIENTS)

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • OTHER SAFETY INFORMATION

    STORE IN A COOL DRY PLACE OR REFRIGERATE

  • PRINCIPAL DISPLAY PANEL

    eczema 1 oz

  • INGREDIENTS AND APPEARANCE
    ECZEMA AND PSORIASIS FREE 
    sambucus nigra flower, calendula officinalis flower, echinacea angustifolia, berberis vulgaris whole salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52810-411
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 100 mL
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER1 [hp_X]  in 100 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 mL
    BERBERIS VULGARIS WHOLE (UNII: 492B79913J) (BERBERIS VULGARIS WHOLE - UNII:492B79913J) BERBERIS VULGARIS WHOLE1 [hp_X]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
    ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52810-411-1130 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2012
    Labeler - PUREMEDY (003552251)
    Establishment
    NameAddressID/FEIBusiness Operations
    COASTAL CONTRACT PACKAGING, INC.137341611manufacture(52810-411)