BURN RELIEF (ARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUM) SPRAY [NATRURAL CREATIONS, INC.]

BURN RELIEF (ARSENIC TRIOXIDE, ATROPA BELLADONNA, LYTTA VESICATORIA, CAUSTICUM, PICRIC ACID, URTICA URENS, HYPERICUM PERFORATUM) SPRAY [NATRURAL CREATIONS, INC.]
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NDC 43406-0631-2
Set ID 79c80c6c-1fd9-4b32-81e0-ff6a1f610227
Category HUMAN OTC DRUG LABEL
Packager Natrural Creations, Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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)

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