Lidocaine, benzalkonium chloride, and dimethicone

FDA label, PureTek Corporation, topical, effective 2025-06-10. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Drug interactions

Check lidocaine, benzalkonium chloride, and dimethicone against a medication list
Label text (1 paragraph)

Drug Interactions Antiarrhythmic Drugs: Diabecin HR™ Cream should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics: When Diabecin HR™ Cream is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Contraindications

CONTRAINDICATIONS: Tuberculosis or fungal lesions of the skin vaccinia, varicella and acute herpes simplex and in persons who have shown hypersensitivity to any of its components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Pregnancy and lactation

Pregnancy

Pregnancy Teratogenic Effects: Pregnancy Category B. Lidocaine has not been studied in pregnancy. Reproduction studies with lidocaine have been performed in rats at doses up to 30 mg/kg subcutaneously and have revealed no evidence of harm to the fetus due to lidocaine. There are, however, no adequate and well- controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, lidocaine should be used during pregnancy only if clearly needed. Labor and Delivery: Lidocaine has not been studied in labor and delivery. Lidocaine is not contraindicated in labor and delivery.

Should lidocaine be used concomitantly with other products containing lidocaine, total doses contributed by all formulations must be considered. Nursing Mothers: Lidocaine has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4. Caution should be exercised when lidocaine is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Lactation

Nursing Mothers: Lidocaine has not been studied in nursing mothers. Lidocaine is excreted in human milk, and the milk: plasma ratio of lidocaine is 0.4. Caution should be exercised when lidocaine is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Therapeutic equivalence (Orange Book)

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