FDA Label for Bioflexor 04
View Indications, Usage & Precautions
Bioflexor 04 Product Label
The following document was submitted to the FDA by the labeler of this product Health Care Laboratories Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Active Ingredient: Purpose:
Menthol 3% ……………………………………………………………………Topical Analgesic
Purpose
Topical analgesic
Inactive Ingredients
Inactive Ingredients: Aloe Vera Juice, Butyl Paraben, Camphor USP, Carbopol Polymer, Edetate Disodium, Ethyl Paraben, Eucalyptus Oil, Isobutyl Paraben, Methyl Paraben, Peacock Blue MX26, 2-Phenoxyethanol, Polysorbate 20, Potassium Sorbate, Propyl Paraben, Purified Water, Sodium Hydroxide, Yerba Mate, Yucca
Warnings Section
Warnings
For external use only.
Do Not Use:
• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions
Ask a doctor before use if you have redness over the affected area.
When using this product:
• avoid contact with the eyes or mucous membranes
• do not bandage tightly
Stop use and ask a doctor if:
• condition worsens or symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation occurs
Keep out of reach of children.
If swallowed, get medical help or contact the Poison Control Center right away.
Dosage And Administration
Directions
- Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily.
- Children under 12 years of age: consult a doctor
Product Description
Description: BioFlexor® gel is an OTC topical analgesic preparation which delivers deep penetrating, effective pain relief. BioFlexor® is a unique product from several viewpoints. In developing BioFlexor®, our main focus was to formulate a potent topical analgesic agent that would minimize the need for oral narcotic analgesics. The result is an exceptional product that truly helps those individuals suffering from the pain associated with the spectrum of medical conditions from arthritis to muscle aches and pain, simple back aches, strains, bruises, and sprains.. Menthol is the only listed active ingredient on the BioFlexor® label. The other all natural components work synergistically to produce the pain relieving activity. Another unique aspect of BioFlexor® relates to the immediate and long-lasting pain relief without the side effects of lingering scent (Methyl Salicylate rubs, ie. Ben Gay), burning sensation (Capsaicin ie. Zostrix, Theragesic, Icy-Hot), greasy residue (ie. Aspercreme, Ben-Gay), and dry skin (alcohol formulations, ie. Biofreeze). The BioFlexor® formulation contains no alcohol, capsaicin, or methyl salicylate.
Mechanism Of Action
Mechanism of Action: The initial pain relief mechanism produced by the absorption of BioFlexor® generates a topical cooling effect. This is a result of vasoconstriction of peripheral vessels in the affected areas, yielding a decreased blood flow. This action causes a decrease in temperature of the skin and subcutaneous tissues. As penetration continues, an interruption of sympathetic nerve conduction occurs, producing a warm vasodilation. This in turn increases the blood flow to muscle tissues and to the surface of the skin, promoting the healing process and rendering analgesic properties
Uses
Temporarily relieves the minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Storage And Handling
Store at 15°-30°C (59°-86°F)
Principal Display Panel
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