Label: LIDOTRAL 3.88% ROLL ON- lidocaine hci gel
- NDC Code(s): 59088-307-07
- Packager: PureTek Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated February 28, 2024
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DESCRIPTIONLidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice ...
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CLINICAL PHARMACOLOGYMechanism of Action:Lidotral® 3.88% Roll on Gelreleases lidocaine from a mild acidic vehicle to stabilize the neuronal membrane by inhibiting the ionic fluxes required for initiation and ...
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INDICATIONSFor the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.
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CONTRAINDICATIONSTuberculous or fungal lesions of skin vaccinia, varicella and acute herpes simplex and in persons who have shown - hypersensitivity to any of its components. Lidocaine is contraindicated - in patients ...
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WARNINGSFor external use only. Not for ophthalmic use.
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PRECAUTIONSIf irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidotral® 3.88% Roll on Gel should be used with caution in ill, elderly, debilitated ...
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ADVERSE REACTIONSDuring or - immediately after treatment, the skin at the site of treatment may - develop erythema or edema or may be the locus of abnormal sensation.
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DOSAGEAdults and children 4 years of age and older: apply a thin film to the affected area(s) two or three times daily or as directed by a licensed healthcare practitioner. See insert for complete ...
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HOW SUPPLIEDLidotral® 3.88% Roll on Gel is supplied in a 3 oz. (85 g) roll on bottle (NDC 59088-307-07).
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STORAGE AND HANDLINGKEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing. Manufactured in the USA by: PureTek ...
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Lidotral® 3.88% Roll on Gel
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INGREDIENTS AND APPEARANCEProduct Information