Label: BURN AIDE- calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, kali bichromicum, picricum acidum, urtica urens 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 November 18, 2022

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

  • ACTIVE INGREDIENTS:

    (in each drop): 8.31% of Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Hypericum Perforatum 30X, Kali Bichromicum 12X, Picricum Acidum 12X, Urtica Urens 12X; 1.75% of Calendula Officinalis 1X, Hypericum Perforatum 1X.

  • PURPOSE:

    May temporarily relieve itching, pain, and swelling associated with minor burns.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • USES:

    May temporarily relieve itching, pain, and swelling associated with minor burns.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    For external use only.

    If pregnant or breast-feeding, ask a health professional before use.

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

    Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Spray on affected area as needed. Shake well before using.

  • INACTIVE INGREDIENTS:

    Water, Ethanol, Glycerin, Aloe vers leaf juice extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 alkyl acrylate crosspolymer, Disodium EDTA, Sodium hydroxide. 

  • QUESTIONS:

    Dist. by Energique, Inc.

    201 Apple Blvd

    Woodbine, IA 51579 800-869-8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEOPATHIC REMEDY

    BURN AIDE

    SPRAY

    6 fl. OZ. (180 ml)

    Burn Aide Spray

  • INGREDIENTS AND APPEARANCE
    BURN AIDE 
    calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, kali bichromicum, picricum acidum, urtica urens spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0662
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 mL
    HYPERICUM PERFORATUM WHOLE (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM WHOLE1 [hp_X]  in 1 mL
    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
    POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE12 [hp_X]  in 1 mL
    PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S) PICRIC ACID12 [hp_X]  in 1 mL
    URTICA URENS WHOLE (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS WHOLE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0662-1180 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/18/2022
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0662) , api manufacture(44911-0662) , label(44911-0662) , pack(44911-0662)