INJURY- arnica montana, calendula officinalis, symphytum officinalis, hypericum perforatum, belladonna, bellis perennis, carbo vegetabilis, hamamelis virginiana, millefolium, rhus tox, ruta graveolens, veratrum album liquid
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.

----------

Drug Facts:

ACTIVE INGREDIENTS:

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

INDICATIONS:

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

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.

DIRECTIONS:

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

INACTIVE INGREDIENTS:

Demineralized water, 25% Ethanol.

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.

INDICATIONS:

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

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

INJURY

1 FL OZ (30 ml)

Injury

INJURY
arnica montana, calendula officinalis, symphytum officinalis, hypericum perforatum, belladonna, bellis perennis, carbo vegetabilis, hamamelis virginiana, millefolium, rhus tox, ruta graveolens, veratrum album liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0160
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X] in 1 mL
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_X] in 1 mL
COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X)	COMFREY LEAF	3 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 1 mL
ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J)	ATROPA BELLADONNA WHOLE	12 [hp_X] in 1 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	12 [hp_X] in 1 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X] in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	12 [hp_X] in 1 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK)	ACHILLEA MILLEFOLIUM	12 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X] in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	12 [hp_X] in 1 mL
VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z)	VERATRUM ALBUM ROOT	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0160-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/17/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2013	01/13/2021

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0160) , api manufacture(43857-0160) , label(43857-0160) , pack(43857-0160)

Revised: 8/2016

Document Id: 91bfe43e-e6e1-4713-a26e-fa565da697ef

Set id: c7f016ec-94bb-48d4-a605-5d0bb9e0e428

Version: 3

Effective Time: 20160809

BioActive Nutritional, Inc.