Otc - Active Ingredient
Menthol 1.25%
Flexigen Cream
FDA Label NDC 72839-371
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Care Research Labs, Llc for the product Flexigen (NDC 72839-371). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain Relieving Cream
Indications & Usage
For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.
Warnings
For external use only. Do not use with other topical pain relievers, with heating pads or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.
Inactive Ingredient
Aloe Barbadensis Leaf Extract, Boswellia Carterii Oil, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Sinensis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglyerin, Glycerin, Glyceryl Stearate SE, Hydrolyzed Rice Protein, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Oil, Stearyl Alcohol, Tocopherol, Water, Xanthan Gum.
Pregnancy
If pregnant or breast-feeding, ask a health professional before use.
* Please review the disclaimer below.
