Label: HOMEOPATHIC BURN- white oxide of arsenic, pot marigold, spanish fly, stinging nettle 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 April 27, 2012

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  • Drug Facts

  • Active Ingredients

    White oxide of arsenic 10X H.P.U.S.*

    Pot Marigold 10X H.P.U.S.*

    Spanish Fly 10X H.P.U.S.*

    Stinging nettle 10X H.P.U.S.*

  • Purpose

    **BR

    **BR

    **BR

    **BR

  • 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 BR indicate Burn Relief.
  • Other Ingredients:

    D.I. Water, Emulsifying Wax, Caprylic/Capric Triglyceride, Propylene Glycol, Mineral Oil, Triethanolamine, Carbomer and Imidazolidinyl urea.
  • Directions:

    Apply directly to affected area, repeat as necessary.
  • Drug Facts (cont.)

  • Uses:

    Use on affected area for relief of irritation, scalded skin, and generalized burns
  • WARNING:

    • for external use only
    • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water

    • Keep out of reach of children

    • If condition worsens or does not improve after regular use of this product as directed or if local irritation or rash occurs, discontinue use and consult a physician.

    Use only if seal is unbroken.
  • Other Information:

    Any Questions?

    1-800-644-8327

    Website:

    BotanicChoice.com

  • Distributed by:

    Indiana Botanic Gardens, Inc. 3401 W. 37th Avenue Hobart, IN 46342
  • Homeopathic Burn Cream

    For generalized burns or scalded skin

    1 oz.

    image of label
  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC BURN 
    white oxide of arsenic, pot marigold, spanish fly, stinging nettle cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE10 [hp_X]  in 28 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER10 [hp_X]  in 28 g
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA10 [hp_X]  in 28 g
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS10 [hp_X]  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TRICAPRYLIN (UNII: 6P92858988)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 934 (UNII: Z135WT9208)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-003-0128 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/27/2012
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASI Marketing Group964366611manufacture(10578-003)
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