Drug Facts:

Drug Facts:
SPL v2
SPL
SPL Set ID c5ed8876-d419-41db-9af3-42d76e1c562e
Route
TOPICAL
Published
Effective Date 2021-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_X]) Arnica Montana (3 [hp_X]) Hypericum Perforatum (6 [hp_X]) Comfrey Root (12 [hp_X]) Bellis Perennis Activated Charcoal Hamamelis Virginiana Root Bark/stem Bark Achillea Millefolium Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Veratrum Album Root
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 2021-05-13

Description

Calendula Officinalis MT, Arnica Montana MT, 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Bellis Perennis 12X, Carbo Vegetabilis 12X, Hamamelis Virginiana 12X, Millefolium 12X, Rhus Tox 12X, Ruta Graveolens 12X, Veratrum Album 12X.


Medication Information

Description

Calendula Officinalis MT, Arnica Montana MT, 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Bellis Perennis 12X, Carbo Vegetabilis 12X, Hamamelis Virginiana 12X, Millefolium 12X, Rhus Tox 12X, Ruta Graveolens 12X, Veratrum Album 12X.

Warnings:

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

For External Use Only.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2-3 times daily.

Indications:

For bumps, bruises, abrasions, strains, sprains, fractures, stiffness. For all body and head injuries.

Active Ingredients:

Calendula Officinalis MT, Arnica Montana MT, 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Bellis Perennis 12X, Carbo Vegetabilis 12X, Hamamelis Virginiana 12X, Millefolium 12X, Rhus Tox 12X, Ruta Graveolens 12X, Veratrum Album 12X.

Inactive Ingredients:

Water, Aloe Vera Leaf Juice Extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Ethanol 3.6%.

Package Label Display:

BIOActive Nutritional

INJURY TOPICAL

HOMEOPATHIC

NET WT 2 OZ (57 g)

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.


Structured Label Content

Warnings: (WARNINGS:)

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

For External Use Only.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

Apply small amount every 10 minutes for 3 doses immediately after injury, then 2-3 times daily.

Indications: (INDICATIONS:)

For bumps, bruises, abrasions, strains, sprains, fractures, stiffness. For all body and head injuries.

Active Ingredients: (ACTIVE INGREDIENTS:)

Calendula Officinalis MT, Arnica Montana MT, 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Bellis Perennis 12X, Carbo Vegetabilis 12X, Hamamelis Virginiana 12X, Millefolium 12X, Rhus Tox 12X, Ruta Graveolens 12X, Veratrum Album 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Aloe Vera Leaf Juice Extract, Benzyl alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Ethanol 3.6%.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

INJURY TOPICAL

HOMEOPATHIC

NET WT 2 OZ (57 g)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

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