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| Product NDC Code | 72667-021 | ||||
|---|---|---|---|---|---|
| Drug Name | Myderm cooling menthol pain relief with 50 percent more menthol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415976 | ||||
| Application Number | part348 | ||||
| Labeler Name | Inspec Solutions LLC. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 4%
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 no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract Arctium Lappa Root (Burdock) Extract Arnica Montana Flower Extract Boswellia Carterii Resin Extract Calendula Officinalis Extract Camellia Sinensis Leaf Extract Camphor Carbomer FD&C Blue #1 FD&C Yellow #5 Full Spectrum Industrial Hemp Extract Glycerin Ilex Paraguariensis (Mate) Leaf Extract Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis (Lemon Balm) Leaf Extract Silica 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 Temporary relief of pain
Purpose
Information about the drug product’s indications for use.Menthol 4% ........... Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.myDerm Cooling Menthol Pain Relief with 50 Percent More Menthol Menthol ISOPROPYL MYRISTATE CALENDULA OFFICINALIS FLOWER FD&C YELLOW NO. 5 SILICON DIOXIDE ARCTIUM LAPPA ROOT CAMPHOR (NATURAL) MELISSA OFFICINALIS LEAF .ALPHA.-TOCOPHEROL ACETATE GREEN TEA LEAF WATER ILEX PARAGUARIENSIS LEAF ISOPROPYL ALCOHOL CARBOMER 940 ALOE VERA LEAF TROLAMINE ARNICA MONTANA FLOWER FRANKINCENSE FD&C BLUE NO. 1 GLYCERIN 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.myDerm Cooling Menthol Pain Relief Gel with 50% More Menthol
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.
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 doctor if, condition worsens, redness is present, irritation develops, 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.DO not use in large quantities over raw surfaces and blistered area When using this product Use only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes
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.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