BURN AIDE- calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, kali bichromicum, picricum acidum, urtica urens spray 
Energique, Inc.

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.

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DRUG FACTS:

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

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)

Revised: 11/2022
Document Id: 55cb3497-7b4c-4443-8f29-d10a4061d5c9
Set id: 62ce13b1-ca8d-4d6b-932d-db13a816bc37
Version: 1
Effective Time: 20221118
 
Energique, Inc.