Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 42baa51d-7116-4cc7-a839-26bcec7640ba
Route
TOPICAL
Published
Effective Date 2013-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (30 [hp_C]) Atropa Belladonna (12 [hp_C]) Bellis Perennis (12 [hp_X]) Bryonia Alba Root (6 [hp_X]) Cupric Cation (10 [hp_X]) Calendula Officinalis Flowering Top Hypericum Perforatum Ledum Palustre Twig Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Comfrey Root Sulfuric Acid Fluoride Ion Phosphate Ion Calcium Cation Ferrosoferric Phosphate Potassium Cation Sulfate Ion Magnesium Cation Sodium Sulfate Anhydrous Chloride Ion
Inactive Ingredients
Aloe Vera Leaf Glycerin Lonicera Japonica Flower Lonicera Caprifolium Flower Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-10-03

Description

Arnica 30C, 6X HPUS, Belladonna 30C,6X HPUS, Bellis 30C, 6X HPUS, Bryonia 12C, 6X HPUS, Cuprum Acet 12X HPUS,Cuprum Sulph 12X HPUS, Calendula 12C, 6X HPUS, Hypericum 30C, 6X HPUS, Ledum 12C HPUS, Rhus Tox 30C, 6X HPUS, Ruta 30C, 6X HPUS, Symphytum 12X HPUS, Sulphuricum Ac 6X HPUS, Calc Fluor 12C,10X HPUS, Calc Phos 10X HPUS, Calc Sulph 6X HPUS, Ferrum Phos 12C, 10X HPUS, Kali Mur 6X HPUS, Kali Phos 6X HPUS, Kali Sulph 6X HPUS, Mag Phos 30C, 10X HPUS, Nat Mur 12X HPUS, Nat Phos 6X HPUS, Nat Sulphuricum 12C, 6X HPUS. The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Purpose

Minor Pain Reliever 


Medication Information

Purpose

Minor Pain Reliever 

Description
Distributed by:



Origin BioMed Inc.

102 Chain Lake Dr, Unit 1K,

Halifax, N.S, Canada, B3S 1A7



MADE IN U.S.A.



www.getbionica.com


Uses
Temporary relief of minor pain associated with:



• arthritis     • strains       • bruises       • sprains       • injuries

• sore muscles and joints



As per Homeopathic Materia Medica.


Do Not
  • apply to wounds, broken or damaged skin  
  • apply over large areas of the body
Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Warnings

FOR EXTERNAL USE ONLY. 

Directions
  • adults and children 2 years of age and older apply liberally to the affected area, rubbing gently until fully absorbed
  • use once every half hour within the first four hours of pain, then 3 times daily

  • children under 2 years of age: consult a physician
Questions?

1-877-Bionica (1-877-246-6422)

Other Information



  • store below 30°C 
  • protect from strong magnetic fields 
  • tamper resistant: do not use if inner protective seal is broken
Active Ingredients

Arnica 30C, 6X HPUS, Belladonna 30C,6X HPUS, Bellis 30C, 6X HPUS, Bryonia 12C, 6X HPUS, Cuprum Acet 12X HPUS,Cuprum Sulph 12X HPUS, Calendula 12C, 6X HPUS, Hypericum 30C, 6X HPUS, Ledum 12C HPUS, Rhus Tox 30C, 6X HPUS, Ruta 30C, 6X HPUS, Symphytum 12X HPUS, Sulphuricum Ac 6X HPUS, Calc Fluor 12C,10X HPUS, Calc Phos 10X HPUS, Calc Sulph 6X HPUS, Ferrum Phos 12C, 10X HPUS, Kali Mur 6X HPUS, Kali Phos 6X HPUS, Kali Sulph 6X HPUS, Mag Phos 30C, 10X HPUS, Nat Mur 12X HPUS, Nat Phos 6X HPUS, Nat Sulphuricum 12C, 6X HPUS.

The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Citrus Lemon (Lemon) Fruit Water, Glycerin, Lonicera japonica (Honeysuckle) Flower Extract, Lonifera Caprifolum (Honeysuckle) Extract, Purified Water 

Principal Display Panel

NDC: 15377-012-03



PAIN RELIEVING

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

ARTHRITIS, STRAINS, BRUISES, SPRAINS, INJURIES, SORE MUSCLES AND JOINTS



• NON-GREASY

• NO CAPSAICIN 

• NO MENTHOL



24 Active Ingredients: including Arnica, Magnesium, Potassium and Calcium



HOMEOPATHIC

NET WT 3 oz (85 g)



When Using This Product
  • avoid contact with eyes or mucus membranes
  • occasionally an increase in skin redness, sensitivity or irritation can occur with initial application. This can be a normal reaction. Discontinue use if skin irritation persists or does not subside.
Stop Use and Ask A Doctor If
  • condition worsens

  • symptoms persist for more than 7 days or clear up and occur again within a few days

  • excessive skin irritation occurs

Structured Label Content

Uses
Temporary relief of minor pain associated with:



• arthritis     • strains       • bruises       • sprains       • injuries

• sore muscles and joints



As per Homeopathic Materia Medica.


Do Not (Do not)
  • apply to wounds, broken or damaged skin  
  • apply over large areas of the body
Description (34089-3)
Distributed by:



Origin BioMed Inc.

102 Chain Lake Dr, Unit 1K,

Halifax, N.S, Canada, B3S 1A7



MADE IN U.S.A.



www.getbionica.com


Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Purpose

Minor Pain Reliever 

Warnings

FOR EXTERNAL USE ONLY. 

Directions
  • adults and children 2 years of age and older apply liberally to the affected area, rubbing gently until fully absorbed
  • use once every half hour within the first four hours of pain, then 3 times daily

  • children under 2 years of age: consult a physician
Questions?

1-877-Bionica (1-877-246-6422)

Other Information



  • store below 30°C 
  • protect from strong magnetic fields 
  • tamper resistant: do not use if inner protective seal is broken
Active Ingredients

Arnica 30C, 6X HPUS, Belladonna 30C,6X HPUS, Bellis 30C, 6X HPUS, Bryonia 12C, 6X HPUS, Cuprum Acet 12X HPUS,Cuprum Sulph 12X HPUS, Calendula 12C, 6X HPUS, Hypericum 30C, 6X HPUS, Ledum 12C HPUS, Rhus Tox 30C, 6X HPUS, Ruta 30C, 6X HPUS, Symphytum 12X HPUS, Sulphuricum Ac 6X HPUS, Calc Fluor 12C,10X HPUS, Calc Phos 10X HPUS, Calc Sulph 6X HPUS, Ferrum Phos 12C, 10X HPUS, Kali Mur 6X HPUS, Kali Phos 6X HPUS, Kali Sulph 6X HPUS, Mag Phos 30C, 10X HPUS, Nat Mur 12X HPUS, Nat Phos 6X HPUS, Nat Sulphuricum 12C, 6X HPUS.

The letters “HPUS” indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Carbomer, Citrus Lemon (Lemon) Fruit Water, Glycerin, Lonicera japonica (Honeysuckle) Flower Extract, Lonifera Caprifolum (Honeysuckle) Extract, Purified Water 

Principal Display Panel

NDC: 15377-012-03



PAIN RELIEVING

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

ARTHRITIS, STRAINS, BRUISES, SPRAINS, INJURIES, SORE MUSCLES AND JOINTS



• NON-GREASY

• NO CAPSAICIN 

• NO MENTHOL



24 Active Ingredients: including Arnica, Magnesium, Potassium and Calcium



HOMEOPATHIC

NET WT 3 oz (85 g)



When Using This Product (When using this product)
  • avoid contact with eyes or mucus membranes
  • occasionally an increase in skin redness, sensitivity or irritation can occur with initial application. This can be a normal reaction. Discontinue use if skin irritation persists or does not subside.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens

  • symptoms persist for more than 7 days or clear up and occur again within a few days

  • excessive skin irritation occurs

Advanced Ingredient Data


Raw Label Data

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