Label: TOPICSKIN- hydrastis canadensis whole, mentha piperita, melissa officinalis cream

  • 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 November 10, 2014

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  • Drug Facts

  • Active Ingredients

    Hydrastis canadensis L. 6X HPUS

    Mentha piperita L. 6X HPUS

    Melissa officinalis L. 6X HPUS

  • Purpose

    Red, dry skin relief

    Natural skin state restoration

    Reddish skin color reduction Clearing of unpleasant patches

  • Uses

    Helps relieve red, dry and irritated skin.

    Helps clear away unpleasant reddish patches.

    Helps restore the skin to its natural state.

  • Warnings

    For external use only

  • Do not use

    for any intended purpose other than indicated above.

  • When using this product

    do not swallow keep away from eyes

    do not use other external care products

  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    When using product for the first time, apply to a small area on the skin and wait for about 10 minutes. If there is no irritation, you may continue use.

    For adults and children 6 months of age and over

    For best results, apply the cream three times a day to clean skin.

  • Inactive Ingredients

    WATER, SUNFLOWER (HELIANTHUS ANNUUS) SEED OIL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, GLYCERIN, SD ALCOHOL 40, DEHYDROACETIC ACID, BENZYL ALCOHOL, LACTIC ACID

  • SPL UNCLASSIFIED SECTION

    The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the U.S. The letters ER indicate Eczema Relief.

    Manufactured by:

    Emilia Cosmetics LTD

    Ha'mada 6, Yokneam

    2069205, Israel

    Made in Israel

    Manufactured for:

    ZBM Natural Medicine Ltd.

    P.O. Box 2227

    Industrial Zone

    Kfar Saba 4464102

    Israel

  • Package Label

    TopicSkin

    Special Cream

    HOMEOPATHIC CREAM FOR THE RELIEF OF SYMPTOMS OF ECZEMA: RASH, BURNING, ITCHING, CHAPPED, DRY, OR CRACKED SKIN: MENTHA PIPERITA L., MELISSA OFFICINALIS L., AND HYDRASTIS CANADENSIS L.

    2.54fl oz (75ml)

    Original Herbal Formula

    Paraben Free

    Fragrance Free

    Colorant Free

    Dermatologically Tested

    To report a serious adverse event, contact

    (210) 880-4960

    Label1

    Label2

  • INGREDIENTS AND APPEARANCE
    TOPICSKIN  
    hydrastis canadensis whole, mentha piperita, melissa officinalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69121-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE6 [hp_X]  in 1 mL
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA6 [hp_X]  in 1 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69121-001-7575 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/10/2014
    Labeler - ZBM Natural Medicine Ltd. (514481212)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emilia Cosmetics Ltd600076624manufacture(69121-001)
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