Drug Facts:

Drug Facts:
SPL v1
SPL
SPL Set ID a1189c23-f8a8-47fd-8a5e-e7d29a676188
Route
ORAL
Published
Effective Date 2016-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_X]) Calendula Officinalis Flowering Top (6 [hp_X]) Hypericum Perforatum (12 [hp_X]) Comfrey Root Atropa Belladonna Whole 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 Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-07-08

Description

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


Medication Information

Description

Arnica Montana 3X, Calendula Officinalis 3X, Hypericum Perforatum 3X, 12X, Symphytum Officinale 6X, Belladonna 12X, 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. 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.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of soreness with exertion, pain and swelling in joints after strain or sprain, and bruised joints, tendons, and ligaments.

Active Ingredients:

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

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Package Label Display:

BIOActive Nutritional

INJURY

HOMEOPATHIC

1 FL OZ (30 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:)

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.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of soreness with exertion, pain and swelling in joints after strain or sprain, and bruised joints, tendons, and ligaments.

Active Ingredients: (ACTIVE INGREDIENTS:)

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

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

INJURY

HOMEOPATHIC

1 FL OZ (30 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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