Label: BURN RELIEF- arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, picric acid, urtica urens, hypericum perforatum spray

  • NDC Code(s): 43406-0631-2
  • Packager: Natrural Creations, Inc.
  • 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 2, 2020

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

  • ACTIVE INGREDIENT

    Active Ingredients (HPUS*): Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Picricum Acidum 12X, Urtica Urens 12X, Hypericum Perforatum 30C.

  • PURPOSE

    Uses:  For the temporary relief of sunburns, burns, and itching skin.**

  • INDICATIONS & USAGE

    Uses: For the temporary relief of sunburns, burns, and itching skin.**

  • DOSAGE & ADMINISTRATION

    Directions:  Spray topically as needed or as directed by a health care professional.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN.  In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • WARNINGS

    WARNINGS:

    • FOR EXTERNAL USE ONLY.
    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
    • Do no use if TAMPER EVIDENT seal is broken or missing.​​​​​​
  • INACTIVE INGREDIENT

    Inactive Ingredients:  Calendula (Marigold Flowering Tops) Extract, Carbomer 940, Ethyl Alcohol USP, Glycerin USP, Hypericum Perforatum (St. John's Wort) Extract, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxymethylglycinate.

  • QUESTIONS

    Questions & Comments?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    *The letters "HPUS" indicate the components in this product are officially monographed in the Homoepathic Pharmacopeia of the United States.

    **These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

  • PRINCIPAL DISPLAY PANEL

    NDC:  43406-0631-2

    BURN RELIEF SPRAY

    HOMEOPATHIC

    2 fl  oz (60 mL) / 12% Alcohol

     UPC:  877730004758

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    arsenic trioxide, atropa belladonna, lytta vesicatoria, causticum, picric acid, urtica urens, hypericum perforatum spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0631
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA12 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA12 [hp_X]  in 1 mL
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM12 [hp_X]  in 1 mL
    PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S) PICRIC ACID12 [hp_X]  in 1 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS12 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0631-260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/30/2016
    Labeler - Natrural Creations, Inc. (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Pharma, Inc.030572478manufacture(43406-0631)