Otc - Active Ingredient
Active Ingredient
Menthol 4%
Lightning Pain Relief Cream
FDA Label NDC 72654-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ebanel Laboratories, Inc for the product Lightning Pain Relief (NDC 72654-013). 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, dosage & administration, warnings, indications & usage, otc - keep out of reach of children, 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
Active Ingredient Purpose
Menthol 4% Topical Analgesic
Dosage & Administration
Directions
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
Warnings
Warnings
■ For external use only.
■ Avoid contact with the eyes.
■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
■ Do not apply to wounds or damaged skin.
■ Do not bandage tightly.
Indications & Usage
Uses
■ For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains. ■ Provides cooling and warming pain relief.
Otc - Keep Out Of Reach Of Children
Other Information
■ Keep away from direct sunlight or heat.
■ Store at room temperature 15°-30°C (59°-86°F).
■ This package is child-resistant. Keep out of reach of children.
■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
■ Do not use this product if seal is broken or missing.
Inactive Ingredient
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Boswellia Serrata Resin Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Cannabis Sativa Seed Oil, Carbomer, Centella Asiatica Leaf Extract, Cinnamomum Camphora (Camphor) Bark Oil, Dimethicone, Dimethyl Isosorbide, Dipotassium Glycyrrhizate, Disodium EDTA, Emu Oil, Ethoxydiglycol, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methyl Sulfonyl Methane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 20, Pyridoxine HCl, Sodium Benzoate, Tocopheryl Acetate, Triethanolamine, Water
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