Otc - Active Ingredient
Menthol 2%, Methyl Salicylate 10%
Doloflex Pain Relief Gel
FDA Label NDC 85350-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Health & Beauty Corp for the product Doloflex Pain Relief (NDC 85350-039). 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, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Indications & Usage
Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.
Warnings
For external use only.
Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin.
When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes.
Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.
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 or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.
Inactive Ingredient
Water, alcohol, carbomer, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-40 Hydrogenated Caster Oil, Aesculus Hippocastanum Seed Extract, Centella Assiatica Leaf Extract, Arnica Montana Flowers Oil, Calendula Officinalis Flower Extract, Triethanolamine.
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