BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]

BURN (AESCULUS HIPPOCASTANUM, ALOE SOCOTRINA, ARNICA MONTANA, BERBERIS VULGARIS, CALENDULA OFFICINALIS, SALICYLICUM ACIDUM, ZINCUM METALLICUM) SPRAY [MBI DISTRIBUTING INC.]
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NDC 58301-181-28
Set ID 9a6f173c-7dcf-4a1c-8817-486eeace753d
Category HUMAN OTC DRUG LABEL
Packager MBI Distributing Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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

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