Lidotral 5 Percent Roll On Gel
Generic: LIDOCAINE HYDROCHLORIDE
Basic Information
Manufacturer
Puretek Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
1c4c9ce5-f12d-9c47-e063-6294a90a0b3c
Indications & Usage
INDICATIONS: For the temporary relief of pain.
Warnings
WARNINGS: For external use only.
Not for ophthalmic use.
PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
Lidotral® 5% Roll on Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.
Use in Pregnancy: Teratogenic Effects; Pregnancy Category B.
Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine.
There are, however, no adequate and well-controlled studies in pregnant women.
Animal reproduction studies are not always predictive of human response.
General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.
Not for ophthalmic use.
PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.
Lidotral® 5% Roll on Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
Carcinogenesis, Mutagenesis and Impairment of Fertility: Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the effect on fertility have not been conducted.
Use in Pregnancy: Teratogenic Effects; Pregnancy Category B.
Reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine.
There are, however, no adequate and well-controlled studies in pregnant women.
Animal reproduction studies are not always predictive of human response.
General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
Nursing Mothers: It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.
Pediatric Use: Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.
Adverse Reactions
ADVERSE REACTIONS: During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.