Bionica Pain Relieving Gel
FDA Label NDC 15377-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Origin Biomed Inc. for the product Bionica Pain Relieving Gel (NDC 15377-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Purpose

Minor Pain Reliever 

Uses

Temporary relief of minor pain associated with:

• arthritis     • strains       • bruises       • sprains       • injuries
• sore muscles and joints

As per Homeopathic Materia Medica.

Warnings

FOR EXTERNAL USE ONLY. 

Do Not

  • apply to wounds, broken or damaged skin  
  • apply over large areas of the body

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

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

Other Information


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

Inactive Ingredients

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

Questions?

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

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

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)

Bionica Carton Label (Bionicacarton)

Bionica Carton Label (Bionicacarton)


* Please review the disclaimer below.