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| Product NDC Code | 71391-128 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Menthol |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | PATCH | ||||||
| RxCUI drug identifier | 1010823 | ||||||
| Application Number | part348 | ||||||
| Labeler Name | Unexo Life Sciences Private Limited | ||||||
| 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 7.5%
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 over 12 years: Gently fold patch in half and remove one side of backing. Apply exposed adhesive to the site of pain. Remove remaining film from the other side and finish applying to skin. Use on affected areas for up to 12 hours. Children 12 years of age or younger: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glyceryl Hydrogenated Rosinate, Mineral Oil, Styrene/Isoprene Copolymer
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 Temporarily relieves minor aches and pains of muscles and joints due to: arthritis simple backache strains sprains bruises
Purpose
Information about the drug product’s indications for use.Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM GLYCEROL ESTER OF HYDROGENATED ROSIN Mineral Oil STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER
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.PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box NDC: 71391-128-05 MENTHOL 7.5% PATCH COOLING PAIN RELIEF PATCH WITH 7.5% NATURAL MENTHOL Backaches, Sore Muscles & Joint Pain Fast Acting Cooling Relief 5 PATCHES 5.51" X 3.94" (14cm X 10cm) PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
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
Manufactured By: UNEXO LIFE SCIENCES PVT. LTD. B-16. Sector 4, Bawana Industrial Area, Delhi – 110039 (INDIA)
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 before use if you have Sensitive skin
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 With other creams, ointments, sprays, liniments, or other topical products containing 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.
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 Call +91 9212228401
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 Excessive irritation or redness is present Condition worsens Pain persists for more than 7 days Symptom 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 Use only as directed Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged skin Do not bandage tightly or use a heating pad
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store in a cool & dry place. Protect from excessive moisture. Do not refrigerate or freeze.
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 Ask a doctor before use if you have Sensitive skin When using this product Use only as directed Avoid contact with eyes and mucous membranes Do not apply to wounds or damaged skin Do not bandage tightly or use a heating pad Stop use and ask a doctor if Excessive irritation or redness is present Condition worsens Pain persists for more than 7 days Symptom clear up and occur again within a few days Do not use With other creams, ointments, sprays, liniments, or other topical products containing menthol. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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