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Product NDC Code | 62742-4219 | ||||
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Drug Name | Joint and muscle pain relief |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M015 | ||||
Labeler Name | Allure Labs | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 1.5%
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 olden Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Glycerin,Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, Glyceryl Stearates, Cetearyl Alcohol,Ceteareth-20, PEG-100 Stearate,Butyrospermum Parkii (Shea) Butter, Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Dimethicone, Dipotassium Glycyrrhizate,Dimethyl Sulfone, Sodium Phytate, Pyridoxine HCI, Methyl Gluceth-20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Boswellia Carterii Oil,Menthe Piperita (Peppermint) Oil,Glucosamine HCI, Citric Acid, Phenoxyethanol,Potassium Sorbate,Sodium Benzoate, Ethylhexylglycerin,Tocopherol, Monoglycerides,Sunflower Oil,Beta-Sitosterol, Squalene,Limonene, Linalool.
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 sprains
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.Joint and Muscle Pain Relief Menthol PYRIDOXINE HYDROCHLORIDE CITRIC ACID MONOHYDRATE SODIUM BENZOATE DIACETYLATED MONOGLYCERIDES GLYCERIN CANNABIS SATIVA SEED OIL ARNICA MONTANA FLOWER CETOSTEARYL ALCOHOL POLYOXYL 20 CETOSTEARYL ETHER PEG-100 STEARATE SHEA BUTTER CETYL ESTERS WAX GLYCERYL MONOSTEARATE MENTHOL MENTHOL WATER PEPPERMINT OIL PHENOXYETHANOL POTASSIUM SORBATE TOCOPHEROL SUNFLOWER OIL .BETA.-SITOSTEROL DIMETHYL SULFONE GLUCOSAMINE HYDROCHLORIDE ETHYLHEXYLGLYCERIN AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ALOE VERA LEAF DIETHYLENE GLYCOL MONOETHYL ETHER DIMETHICONE GLYCYRRHIZINATE DIPOTASSIUM SQUALENE LINALOOL, (+/-)- LIMONENE, (+)- METHYL GLUCETH-20 TEA TREE OIL FRANKINCENSE OIL
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.Joint & Muscle pain relief
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 on wounds or damaged skin
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 of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store in a cool, dry place away from light If pregnant or breast-feeding, ask a health professional before use
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens irritation occurs symptoms persist for more than 7 days or clear up and occur again within a few days
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes do not bandage tightly
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
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