Otc - Active Ingredient
Menthol USP 2.25%
Flexacure
FDA Label NDC 71402-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Symedic Llc for the product Flexacure (NDC 71402-007). 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 otc - active ingredient, dosage & administration, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Apply as needed.
Warnings
(for external use only)
Otc - When Using
When using this product
• use only as directed
• do not bandage tightly or use with heating pad
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged skin
Otc - Stop Use
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 • redness is present • irritation develops
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.
Instructions For Use
adults and children 12 years of age and older:
• apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat if necessary, but not more than 3 to 4 times daily
children under 12 years of age: ask a doctor
Inactive Ingredient
Arnica Montana Flower Extract, Chondroitin Sulfate, Dimethyl Sulfone USP (MSM), Dimethyl Sulfoxide USP (DMSO), Glucosamine HCL (Shellfish), Glycerin, Hydrogen Peroxide, Magnesium Chloride, Propylene Glycol, Water (Aqua)
Other Safety Information
Persons with a known allergy to shellfish or sulfur should not use this product
Statement Of Identity
Dist. by: Symedic LLC Las Vegas, NV 89147
MADE IN USA ©2019 FlexaCure
www.flexacure.com
Indications & Usage
Uses: Temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains
• sprains • bruises • cramps
Otc - Purpose
Topical Analgesic
* Please review the disclaimer below.
