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| Product NDC Code | 71391-127 | ||||
|---|---|---|---|---|---|
| Drug Name | Menthol 5% hydrogel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | part348 | ||||
| Labeler Name | Unexo Life Sciences, Private Limited | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 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 12 years of age and over: Carefully remove backing from patch. Applu sticky side of patch to affected area. Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients acrylates copolymer, alcohol, carboxymethylcellulose sodium, edetate Disodium, dihydroxyaluminium aminoacetate, glycerine, kaolin, methylparaben, polysorbate 80, polyvinyl alcohol, propylparaben, PVP, sodium polyacrylate, sorbitan oleate, sorbitol, tartaric Acid, titanium Dioxide, 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.Use For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps
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 5% Hydrogel MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 MW) Alcohol CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Edetate disodium Dihydroxyaluminum aminoacetate Glycerin Kaolin Methylparaben Polysorbate 80 Polyvinyl alcohol, unspecified Propylparaben Povidone, unspecified Sodium polyacrylate (2500000 MW) Sorbitan monooleate Sorbitol Tartaric acid Titanium dioxide Water
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 Carton NDC 71391-127-05 UNEXO'S MENTHOL 5% HYDROGEL PATCH 5% Menthol BACK & LARGE AREAS Targeted, Long-Lasting Pain Relief TOPICAL ANALGESIC Adhesive Fabric Patch No-Mess Application Single Use 5 PATCHES 7.87 IN. X 3.93 IN. (20 cm × 10 cm) Compare to Extra Strength Icy Hot ® Medicated Patch active ingredient* PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Carton
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 in India By: Unexo Life Sciences Pvt. Ltd. B-16, Sector 4, Bawana Industrial Area, Delhi - 110039 (INDIA)
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. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre 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 consult a 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 You experience signs of skin injury such as pain, swelling, or blistering where the product was applied.
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 Rare cases of serious burns have been reported with products of this type Don't bandage tightly or use with a heating pad Avoid contact with eyes or mucous membranes Don't apply to wounds or damaged skin Do not use at the same time as other topical analgesics
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant of breastfeeding, ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature below 86°F (30°C)
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 When using this product Use only as directed Rare cases of serious burns have been reported with products of this type Don't bandage tightly or use with a heating pad Avoid contact with eyes or mucous membranes Don't apply to wounds or damaged skin Do not use at the same time as other topical analgesics Stop use and consult a 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 You experience signs of skin injury such as pain, swelling, or blistering where the product was applied. If pregnant of breastfeeding, ask a health professional before use Keep Out of Reach of Children. Do not use on infants. If swallowed, seek medical help or contact a Poison Control Centre 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