Otc - Active Ingredient
Menthol 5.00%
Capsaicin 0.0375%
Flexin
FDA Label NDC 69695-1974
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Whyteman Labs Llc for the product Flexin (NDC 69695-1974). 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, uses :, warnings :, otc - keep out of reach of children, otc - do not use, otc - stop use, directions :, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic/Counterirritant
External Analgesic
Uses :
Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, sprains, muscle soreness and stiffness.
Warnings :
- For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
- Do not cover with bandage.
- Do not use on wounds or damaged skin.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. Consult physician for use in children under 12.
Otc - Do Not Use
- Do not use if you are allergic to Menthol or Capsaicin.
Otc - Stop Use
- Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occurs again within a few days, or if rash, itching or excessive skin irritation occurs.
Directions :
- Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily.
- Children under 12 years, consult a physician before use.
- How to apply:
- Clean and dry affected area.
- Cut open pouch and remove patch. Remove protective film and apply directly to area of pain.
- Apply to affected area not more than 3 times daily.
- Wash hands with soap after applying patch.
- Reseal pouch containing unused patches.
Inactive Ingredients :
Water, Glycerine, Sodium Polyacrylate, Polysorbate 80,
Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,
Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben.
Storage And Handling
Store below 25°C (77°F)
Avoid direct sunlight.
Principal Display Panel
Flexin Label (Flexin Label For Print 07v)
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