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Myderm cooling menthol pain relief with 50 percent more menthol - Medication Information

Product NDC Code 72667-021
Drug Name

Myderm cooling menthol pain relief with 50 percent more menthol

Type Brand
Active Ingredients
Menthol 6 g/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 415976
Application Number part348
Labeler Name Inspec Solutions LLC.
Packages
Package NDC Code Description
72667-021-01 89 ml in 1 bottle, plastic (72667-021-01)
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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