The following Structured Product Label (SPL) was submitted to the FDA by Gensco Laboratories, Llc for the product Lidodose (NDC 35781-0301). 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 dosage and administration, usage, warning: for external use only., keep out of reach of children, storage, active ingredients:, purpose:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Adults and children 2 years of age and older: Apply using a gloved hand. Swirl the applicator tip prior to removing swab from the ouch and apply to area 3-5 minutes prior to procedure not more than 4 times daily.
Children under 2 years of age: consult a physician.
Pain relief
Avoid contact with eyes.
Stop use and consult a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. So not use in large quanities, particulary over raw surfaces or blistered areas.
If swallowed, get medical help or contact a Poison Control Center right away.
Store between 68 and 77 F (20 - 25 C), with allowed excursions between 59 and 86 F (15 - 30 C). Protect from freezing. (See USP Controlled Room Temperature).
Lidocaine Hydrochloride 3%
Anesthetic
Aqua (Deionized Water), Carbomer, Isopropyl Alcohol, Petrolatum, Polysorbate-20, Triethanolamine
Please see product insert for additional information.
* Please review the disclaimer below.
