2.5% Menthol Pain Relief Gel
FDA Label NDC 52000-440
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product 2.5% Menthol Pain Relief (NDC 52000-440). 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 drug facts, active ingredient (in each gram), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Gram)
Menthol 2.5%
Purpose
Topical analgesic
Uses
• temporarily relieves the minor aches and pains of muscles and joints associated with: • simple backache • arthritis • strains • bruises • sprains
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 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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.
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: ask a doctor
Other Information
• store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Cinnamomum camphora(camphor) bark oil, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Methylparaben, Polysorbate 20, Propylparaben, Purified Water, Sodium Hydroxide.
Packaging
2.5% Menthol Pain Relief (52000440 2)
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