Lido-Rx Cream

Generic name: lidocaine, capsaicin
Dosage form: cream

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION

Disclaimer: The FDA has not evaluated this drug, and FDA has not approved this labeling.

Lido-Rx 4.1 is a Lidocaine 4% and Capsaicin 0.1% cream which is a topical anesthetic and

analgesic indicated for the relief of pain related to minor cuts, grazes and irritation.

NOTE: There is no menthol in this product.

INDICATIONS AND USAGE

Lido-Rx 4.1 is a topical anesthetic and analgesic indicated for the relief of pain related to minor cuts,

grazes and irritations.

WARNINGS

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 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.

Precautions

If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy.

Lido-Rx 4.1 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.

NURSING MOTHERS:

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.

PEDIATRIC USE:

Dosage in pediatric patients should be reduced commensurate with age, body weight, and physical condition.

ADVERSE REACTIONS:

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or

may be the loc