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| Product NDC Code | 10742-8386 | ||||
|---|---|---|---|---|---|
| Drug Name | Mentholatum lidocaine heat |
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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 | ||||
| RxCUI drug identifier | 1010895 | ||||
| Application Number | part348 | ||||
| Labeler Name | The Mentholatum Company | ||||
| 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 Lidocaine HCl 4%
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 and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimethicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, glycerin, glyceryl monostearate, phenoxyethanol, polysorbate 20, purified water, steareth-21, vanillyl butyl ether
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 pain
Purpose
Information about the drug product’s indications for use.Purpose Lidocaine HCl - Topical anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Mentholatum Lidocaine Heat Lidocaine HCl CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALCOHOL ALOE VERA LEAF AMINOMETHYLPROPANOL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CAPRYLYL TRISILOXANE CETOSTEARYL ALCOHOL CETETH-20 PHOSPHATE CHLORPHENESIN DIHEXADECYL PHOSPHATE DIMETHICONE EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE PHENOXYETHANOL POLYSORBATE 20 WATER STEARETH-21 VANILLYL BUTYL ETHER 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.Package/Label Principal Display Panel Mentholatum Lidocaine Heat
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 large areas of the body or on cut, irritated or blistered skin on puncture wounds for more than one week without consulting a doctor
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 persist for more than 7 days or clear up and occur again within a few days redness, rash, or irritation occurs
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 do not get into eyes do not bandage tightly or apply external heat to the area of use
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 on large areas of the body or on cut, irritated or blistered skin on puncture wounds for more than one week without consulting a doctor When using this product use only as directed do not get into eyes do not bandage tightly or apply external heat to the area of use Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness, rash, or irritation occurs
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