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Product NDC Code | 63742-013 | ||||||
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Drug Name | Lightning pain relief |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
RxCUI drug identifier | 1148430 | ||||||
Application Number | M017 | ||||||
Labeler Name | Clinical Resolution Laboratory, Inc. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 4% Purpose Topical Analgesic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Lightning Pain Relief MENTHOL ALLANTOIN ALOE VERA LEAF ARNICA MONTANA FLOWER INDIAN FRANKINCENSE SHEA BUTTER C13-14 ISOPARAFFIN CANNABIS SATIVA SEED OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE CENTELLA ASIATICA LEAF CAMPHOR OIL DIMETHICONE DIMETHYL ISOSORBIDE GLYCYRRHIZINATE DIPOTASSIUM EDETATE DISODIUM ANHYDROUS EMU OIL DIETHYLENE GLYCOL MONOETHYL ETHER EUCALYPTUS OIL GLYCERIN GLYCERYL MONOSTEARATE SUNFLOWER OIL ISOPROPYL MYRISTATE LAURETH-7 LAVENDER OIL TEA TREE OIL PEG-100 STEARATE PHENOXYETHANOL POLYSORBATE 20 PYRIDOXINE HYDROCHLORIDE SODIUM BENZOATE .ALPHA.-TOCOPHEROL ACETATE TROLAMINE WATER MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labeling: Label
Package Labeling:101g Label2
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
Other Information Keep away from direct sunlight or heat. Store at room temperature 15°-30° C (59°-86°F).
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use this product if seal is broken or missing.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach od children. In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. Keep out of reach od 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API