BURN AIDE- calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, picricum acidum, urtica urens spray
BioActive Nutritional, 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:

Calendula Officinalis MT, Hypericum Perforatum MT, 30X, Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Picricum Acidum 12X, Urtica Urens 12X.

ACTIVE INGREDIENTS:

Calendula Officinalis MT, Hypericum Perforatum MT, 30X, Arsenicum Album 12X, Belladonna 12X, Cantharis 12X, Causticum 12X, Picricum Acidum 12X, Urtica Urens 12X.

INDICATIONS:

For temporary relief of minor burns.

WARNINGS:

For external use only.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

Do not get in your eyes. If you get Burn Aide in your eyes, rinse immediately with cool tap water. In case of serious burns, consult a doctor. If your symptoms do not get better in seven days or if they get worse, check with your doctor.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Clean the affected area. Spray on affected area as needed.

INDICATIONS:

For temporary relief of minor burns.

INACTIVE INGREDIENTS:

Demineralized Water, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 10.7% Ethanol.

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

BURN AIDE

4 FL OZ (120 ml)

Burn Aide

BURN AIDE
calendula officinalis, hypericum perforatum, arsenicum album, belladonna, cantharis, causticum, picricum acidum, urtica urens spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0367
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X] in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	12 [hp_X] in 1 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	12 [hp_X] in 1 mL
PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S)	PICRIC ACID	12 [hp_X] in 1 mL
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0367-1	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/21/2015	08/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/21/2015	08/31/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0367) , api manufacture(43857-0367) , label(43857-0367) , pack(43857-0367)

Revised: 3/2018

Document Id: 2af8803c-b442-450e-83ab-e0e0c4aa0b2f

Set id: 22c891c9-beb1-42eb-ba23-142176a016a2

Version: 2

Effective Time: 20180301

BioActive Nutritional, Inc.