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| Product NDC Code | 84007-333 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol roll on |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID, EXTENDED RELEASE | ||||
| Application Number | M017 | ||||
| Labeler Name | Medhome Pharma Inc | ||||
| 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% ...... 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.Dosage 74 mL in 1 BOTTLE
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Isopropyl Myristate, Ilex Paraguariensis Leaf Extract, Silica, Triethanolamine, Vitamin E, 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.Directions Adults and children 12 years of age and older: • Rub a thin film over affected areas not more than 4 times daily; • Message not necessary Children under 12 years of age: Consult physician. Wash hands after use with cool water.
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.MENTHOL ROLL ON pain relief gel WATER SILICON DIOXIDE ILEX PARAGUARIENSIS LEAF .ALPHA.-TOCOPHEROL, D- GLYCERIN GREEN TEA LEAF CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE ARNICA MONTANA FLOWER FD&C BLUE NO. 1 ISOPROPYL MYRISTATE TROLAMINE ALOE VERA LEAF FRANKINCENSE CAMPHOR (SYNTHETIC) MENTHOL MENTHOL ALCOHOL 95% FD&C YELLOW NO. 5
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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.... ask a doctor if • skin reactions such as redness, swelling, blistering or other discomfort occur • symptoms persist for more than 7 days
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 • with a heating pad or device • with other ointments, creams, sprays, or liniments • if you are allergic to any ingredients of this product
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 accidentally, get medical help or contact with Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments: cs@medhomegroup,com
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 ... if • skin reactions such as redness, swelling, blistering or other discomfort occur • symptoms persist for more than 7 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 • use only as directed • avoid contact with the eyes, mucous membranes, or rashes • do not bandage tightly
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, Ask a health professional before use.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.Uses Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, ankle, back, neck, hips, shoulders, elbows.
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