Active Ingredient(S)
Lidocaine HCl 3%
Lidomar Lotion
FDA Label NDC 85477-326
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncora Pharma, Llc for the product Lidomar (NDC 85477-326). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, use(s), warnings, directions, storage, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic — for temporary relief of minor pain and itching.
Use(S)
For the temporary relief of pain and itching associated with:
- minor burns
- sunburn
- minor cuts
- scrapes
- insect bites
- minor skin irritations
- rashes due to poison ivy
- rashes due to poison oak
- rashes due to poison sumac
Warnings
For external use only. Do not use if you are allergic to lidocaine or any of the ingredients. Avoid contact with eyes. Keep out of reach of children.
Directions
Apply to the affected area 3 to 4 times daily or as directed by a healthcare provider.
Storage
Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F). [See USP Controlled Room Temperature].
Keep out of reach of children.
Inactive Ingredients
Water, cetyl alcohol, glyceryl stearate, PEG-75 stearate, ceteth-20, steareth-20, cyclopentasiloxane, dimethicone, capric/capryl triglyceride, Prunus amygdalus dulcis (sweet almond) oil, stearyl alcohol, phenoxyethanol, ethylhexylglycerin, sodium hydroxide, lactic acid.
Principal Display Panel
Lidomar™
Lidocaine 3% Lotion
NDC 85477-311-07
Net Wt. 6 oz (177 mL)
Pdp (Lidomar 1)
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