Renovo Lido5 Recall
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Questions & Answers
Side Effects & Adverse Reactions
For external use only.
Use only as directed.
Avoid contact with eyes and mucous membranes.
Do not cover with bandage.
Do not use on wounds or damaged skin.
Consult physician for children under 12.
Do not use if you are allergic to Menthol, Capsaicin or Lidocaine
Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
KEEP OUT OF REACH OF CHILDREN.
If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Renovo Lido5 Cream 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.
Lidocaine is excreted in human milk. The clinical significance of this observation is unknown. Caution should be exercised when lidocaine is administered to a nursing woman.
Dosage in pediatric patients should be reduced commensurate with age, body weight, and physical condition.
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.
CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Renovo Lido5 is a topical anesthetic and analgesic indicated for the relief of pain related to minor cuts, grazes and irritations.
There is currently no drug history available for this drug.
Disclaimer: The FDA has not evaluated this drug, and FDA has not approved this labeling.
Renovo Lido5 is a Lidocaine 5%, Menthol 3% and Capsaicin 0.05% cream which is a topical anesthetic and analgesic indicated for the relief of pain related to minor cuts, grazes and irritation