Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 66f41f76-7c1f-4bd4-a6f1-cba9647c4f5c
Route
TOPICAL
Published
Effective Date 2019-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Hypericum Perforatum (12 [hp_X]) Arsenic Cation (3+) Atropa Belladonna Lytta Vesicatoria Causticum Picric Acid Urtica Urens
Inactive Ingredients
Water Aloe Vera Leaf Benzyl Alcohol Ethylhexylglycerin Tocopherol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Edetate Disodium Anhydrous Sodium Hydroxide Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-03-13

Description

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


Medication Information

Description

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

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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

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

Indications:

For temporary relief of minor burns.

Active Ingredients:

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

Inactive Ingredients:

Demineralized Water, Aloe Vera Thickened Gel (Aloe Barbadensis Leaf Juice, Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA Sodium Hydroxide), 10.7% Ethanol.

Package Label Display:

BIOActive Nutritional

BURN AIDE

HOMEOPATHIC

4 FL OZ (120 ml)

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.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

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

Indications: (INDICATIONS:)

For temporary relief of minor burns.

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, Aloe Vera Thickened Gel (Aloe Barbadensis Leaf Juice, Water, Benzyl Alcohol (and) Ethylhexylglycerin (and) Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA Sodium Hydroxide), 10.7% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

BURN AIDE

HOMEOPATHIC

4 FL OZ (120 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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