Active Ingredients (% W/W)
Lidocaine 3.88%
Menthol 3%
Lidochill(tm) Gel
FDA Label NDC 59088-240
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Lidochill(tm) Gel (NDC 59088-240). 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 ingredients (% w/w), purposes, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
Topical Anesthetic (Lidocaine 3.88%)
Topical Analgesic (Menthol 3%)
Uses
for the temporary relief of minor pain, itching and irritation due to / associated with
■ simple backache ■ arthritis ■ sprains ■ muscle strains ■ bruises
■ minor cuts/scrapes ■ minor burns/sunburn ■ insect bites
Warnings
For external use only
Do Not Use
■ if allergic to lidocaine or any other local anesthetics
■ over a large skin area ■ on deep puncture wounds ■ on infections
■ on raw surfaces or blistered areas
When Using This Product
■ do not get into eyes ■ do not use in large quantities
■ do not bandage or apply heat to treated areas
■ wash hands immediately after using
Stop Use And Ask A Doctor If
■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ Adults and children over 12 years of age: apply a thin layer to the affected area up to 3 to 4 times a day
■ Children 12 years of age or younger: consult a doctor
Other Information
■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)
Inactive Ingredients
Aminomethyl Propanol, Carbomer, Ceteareth-20, Cetyl Ethylhexanoate, Cetyl Phosphate, Diisobutyl Adipate, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate SE, Phenoxyethanol, Purified Water, Stearic Acid.
* Please review the disclaimer below.
