Label: ITCHY GONE- apis mellifica, belladonna, calcarea carbonica, medusa, mezereum, rhus toxicodendron, astacus fluviatilis, chloralum, gel

  • 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 January 26, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  Apis mellifica 12X, Belladonna 12X, Calcarea carbonica 12X, Medusa 12X, Mezereum 12X, Rhus toxicodendron 12X, Astacus fluviatilis 15X, Chloralum 15X.

  • PURPOSE

    INDICATIONS:  For temporary relief of minor itchy skin irritations; inflammation and rashes due to eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry; genital and anal itching.

  • WARNINGS

    WARNINGS:  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.

    Do not use if tamper evident seal is broken or missing.

    Store in a cool, dry place.

    For topical use only.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Apply topically to affected area 4 to 6 times daily.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Aloe, Biosaccharide gum-1, Carbomer, Ethanol, Glycerin, NaPCA, Purified water, Sodium hydroxymethylglycinate, Tromethamine.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.  If swallowed, get medical help or contact Poison Control Center right away.

  • INDICATIONS & USAGE

    INDICATIONS:  For temporary relief of minor itchy skin irritations; inflammation and rashes due to eczema, dermatitis, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry; genital and anal itching.

  • QUESTIONS

    Dist. By:

    MedCare Group

    Boothwyn, PA 19060

    302-260-3111

    www.medcaregroups.com


  • PRINCIPAL DISPLAY PANEL

    MEDCARE

    Itchy Gone

    HOMEOPATHIC

    Net Wt. 2 OZ

    Itchy Gone

  • INGREDIENTS AND APPEARANCE
    ITCHY GONE 
    apis mellifica, belladonna, calcarea carbonica, medusa, mezereum, rhus toxicodendron, astacus fluviatilis, chloralum, gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-0777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 1 g
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 g
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]  in 1 g
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK12 [hp_X]  in 1 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]  in 1 g
    ASTACUS ASTACUS (UNII: V0551986XQ) (ASTACUS ASTACUS - UNII:V0551986XQ) ASTACUS ASTACUS15 [hp_X]  in 1 g
    CHLORAL HYDRATE (UNII: 418M5916WG) (CHLORAL - UNII:FLI06WS32H) CHLORAL HYDRATE15 [hp_X]  in 1 g
    PHYSALIA PHYSALIS (UNII: KT9FN2JQGF) (PHYSALIA PHYSALIS - UNII:KT9FN2JQGF) PHYSALIA PHYSALIS12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-0777-159.69 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/28/2011
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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