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| Product NDC Code | 59088-587 | ||||
|---|---|---|---|---|---|
| Drug Name | Pharmapurerx menthotral |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M015 | ||||
| Labeler Name | PureTek Corporation | ||||
| 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 ingredients (% w/w) Lidocaine 3.88% Menthol 3%
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 of age: apply a thin layer to the affected area up to 3 to 4 times a day ■ 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 Aminomethyl Propanol, Carbomer, Ceteareth-20, Cetyl Ethylhexanoate, Cetyl Phosphate, Diisobutyl Adipate, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate SE, Phenoxyethanol, Purified Water, Stearic Acid.
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 for the temporary relief of minor pain, itching and irritation due to / associated with ■ simple backache ■ arthritis ■ sprains ■ muscle strains ■ bruises ■ minor cuts/scrapes ■ minor burns/sunburn ■ insect bites
Purpose
Information about the drug product’s indications for use.Purposes Topical Anesthetic (Lidocaine 3.88%) Topical Analgesic (Menthol 3%)
Spl product data elements
Usually a list of ingredients in a drug product.PharmapureRx Menthotral lidocaine, menthol AMINOMETHYLPROPANOL CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) POLYOXYL 20 CETOSTEARYL ETHER CETYL ETHYLHEXANOATE CETYL PHOSPHATE DIISOBUTYL ADIPATE EDETATE DISODIUM GLYCERIN GLYCERYL STEARATE SE PHENOXYETHANOL WATER STEARIC ACID LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE 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.PharmapureRx ® Menthotral™ Cream (Lidocaine 3.88% / Menthol 3%) Topical Use Only Manufactured in the USA by: PureTek Corporation San Fernando, CA 91340 877-921-7873 image description
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 ■ if allergic to lidocaine or any other local anesthetics ■ over a large skin area ■ on deep puncture wounds ■ on infections ■ on raw surfaces or blistered areas
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 a doctor if ■ condition worsens ■ symptoms last 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.When using this product ■ do not get into eyes ■ do not use in large quantities ■ do not bandage or apply heat to treated areas ■ wash hands immediately after using
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information ■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)
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 Do not use ■ if allergic to lidocaine or any other local anesthetics ■ over a large skin area ■ on deep puncture wounds ■ on infections ■ on raw surfaces or blistered areas When using this product ■ do not get into eyes ■ do not use in large quantities ■ do not bandage or apply heat to treated areas ■ wash hands immediately after using Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. 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