Label: BURN- aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zincum metallicum spray

  • 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 July 28, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Aesculus hippocastanum 4x, Aloe socotrina 4x, Arnica montana 4x, Berberis vulgaris 4x, Calendula officinalis 4x, Salicylicum acidum 2x, Zincum metallicum 3x

  • INACTIVE INGREDIENT

    deionized water, propylene glycol, polysorbate 20, glycerine, sodium bicarbonate, MSM, Dimethylaminoethanol, citric acid, potassium sorbate, benzyl alcohol, trace minerals (trona), avocado oil, and vitamin E

  • INDICATIONS & USAGE

    Temporarily relieves symptoms of minor burns, superficial scalds, sunburn, and other minor skin irritations such as:

    • redness
    • stinging
    • burning
    • itching
    • minor pain
    • dryness
    • as per homeopathic materia medica
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 3 years of age and older:
    • clean the burned area(s)
    • apply topically as needed not more than 12 times daily
    • area may be covered with a sterile bandage
    • children under 3 years of age: consult a physician


  • PURPOSE

    Aesculus hippocastanum...................................................Venous Stasis

    Aloe socotrina...........................................................................Redness

    Arnica montana...........................................................................Burning

    Berberis vulgaris..........................................................................Burning

    Calendula officinalis.....................................................................Healing

    Salicylicum acidum.......................................................Burning and Heat

    Zincum metallicum.............................................................Pain Reliever

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • WARNINGS

    For external use only.

  • QUESTIONS

    Questions?

    1.800.321.3740
    Mon-Fri, 9am-5pm
  • PRINCIPAL DISPLAY PANEL

    Burn Spray Carton

  • DO NOT USE

    Do not

    • use if you are allergic to salicylates (although this product does not contain aspirin)
    • use in the eyes
    • apply over large areas of the body
    • use longer than 1 week unless directed by a doctor
    • ingest


  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns.

  • WHEN USING

    When using this product

    • use only as directed
    • test on a small area before use.  This product may cause allergic reaction in some individuals.
    • wash hands before and after using
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • if symptoms persist for more than 7 days or clear up and occur again within a few days
    • excessive skin irritation occurs
  • STORAGE AND HANDLING

    • store at room temperature
    • Tamper Evident:  Do not use if imprinted seal around cap is broken or missing.
  • INGREDIENTS AND APPEARANCE
    BURN 
    aesculus hippocastanum, aloe socotrina, arnica montana, berberis vulgaris, calendula officinalis, salicylicum acidum, zincum metallicum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58301-181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M) AESCULUS HIPPOCASTANUM FLOWER4 [hp_X]  in 60 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE4 [hp_X]  in 60 mL
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA4 [hp_X]  in 60 mL
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK4 [hp_X]  in 60 mL
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]  in 60 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 [hp_X]  in 60 mL
    ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE HEPTAHYDRATE3 [hp_X]  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58301-181-2860 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/01/2010
    Labeler - MBI Distributing Inc. (196786545)
    Registrant - MBI Distributing Inc. (196786545)
    Establishment
    NameAddressID/FEIBusiness Operations
    MBI Distributing Inc.196786545manufacture