Label: BYE BYE BURNS- topical skin spray 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 December 4, 2017

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  • Bye Bye Burns

    Belladonna 6X

    Cantharis 6X

    Ranunculus bulbosa 6X

    Urtica dioica 6X

  • Bye Bye Burns

    Natural coconut oil, virgin olive oil, omega-3 shark liver oil, natural vitamin E.

  • Bye Bye Burns

    Avoid contact with eyes. If symptoms persist for more than 7 days, discontinue use and contact your health care professional. In case of accidental overdose seek professional assistance or contact a poison control center immediately. All the ingredients are edible, but this product is not intended for internal use. Avoid spraying on clothing as the product will stain. In case of severe burns, or burns over large areas of the body, consult a doctor. Stop use and consult a doctor if the conditions persist or get worse.

  • Bye Bye Burns

    Keep out of reach of children.

  • Bye Bye Burns

    For the temporary relief of skin burns and pain from contact with hot surfaces, scalding, and from the sun. For the temporary reief of vesicular eruptions like blisters, and inflammation after a burn.

  • Bye Bye Burns

    Adults or children over 2 years of age, apply to affected area up to 3-4 times daily. The harder you depress the sprayer cap, the more it will be directed in a stream rather than in a mist. Most of the oil will absorb directly into the skin within 15 minutes of application.

  • Bye Bye Burns

    Belladonna  - burning of the skin from contact

    Cantharis  - burns, scalds, and inflammation of the skin

    Ranunculus bulbosa - blistering of the skin after a burn

    Urtica dioica - burns, scalds, sunburns and itching from burns.

  • Bye Bye Burns

    CartonLabel

  • INGREDIENTS AND APPEARANCE
    BYE BYE BURNS 
    topical skin spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA6 [hp_X]  in 1 mL
    RANUNCULUS BULBOSUS (UNII: AEQ8NXJ0MB) (RANUNCULUS BULBOSUS - UNII:AEQ8NXJ0MB) RANUNCULUS BULBOSUS6 [hp_X]  in 1 mL
    URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-046-021 in 1 CARTON08/23/2004
    1NDC:64616-046-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/23/2004
    Labeler - Vitality Works, Inc (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-046)
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