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Product NDC Code | 72667-008 | ||||
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Drug Name | Myderm |
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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 | GEL | ||||
RxCUI drug identifier | 1011849 | ||||
Application Number | part348 | ||||
Labeler Name | Inspec Solutions LLC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Lidocaine ............. 0.5%
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.Direction Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day Children under 2 years of age: consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.
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.Temporary relief of pain and itching due to - sunburn - minor burn - insect bites - minor cuts - scraps
Purpose
Information about the drug product’s indications for use.Lidocaine 0.5% ............. Pain Reliever
Spl product data elements
Usually a list of ingredients in a drug product.MyDerm Lidocaine WATER GLYCERIN ISOPROPYL ALCOHOL MENTHOL PROPYLENE GLYCOL 2-STEARATE TROLAMINE SALICYLATE ALOE VERA LEAF CARBOMER 1342 DIAZOLIDINYL UREA DISODIUM HEDTA POLYSORBATE 80 FD&C YELLOW NO. 5 FREE ACID LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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.Pain Reliever ALOE GEL Lidocain HCI 0.5%
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 product is 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.Sop use and ask a doctor system persist for more than 7 days.
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 keep out of eyes Rinse with warter to remove
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