Drug Facts
Active ingredient ................Purpose
Lidocaine USP 4.0%.......................Topical Analgesic
Lidocaine Pain Relief Roll On Liquid
FDA Label NDC 13709-360
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Lidocaine Pain Relief Roll On (NDC 13709-360). 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 drug facts, uses, ask a doctor, warnings, when using this product, stop use, if pregnant or breast-feeding, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
For the temporary relief of pain associated with
■ minor aches and pains associated with sore muscles
■ strains
■ joint discomfort
■ arthritis
■ tendiniti
Ask A Doctor
Ask a doctor before using if you have sensitive skin.
Warnings
For external use only
When Using This Product
When using this product
■ Avoid contact with eyes and mucous membranes.
■ Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops.
■ Do not bandage or use with a heating pad or device, ointments, creams, sprays or liniments.
■ Wash hands with cool water after using.
Stop Use
Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days, or clear up and reoccur
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use
Dosage And Administration
■ Adults/Children 2 years and older: Roll on the affected area up to 4 times daily.
■ Children under 2 years of age: Consult a physician
Other Information
If pregnant or breast-feeding, ask a health professional before use.
Inactive Ingredients
benzyl alcohol, carbomer homopolymer type C, cholesterol NF, hydrogenated lecithin, polysorbate 80, propylene glycol USP, purified water, tocopheryl acetate dl USP, triethanolamine
Questions/Concerns
Questions or comments? 1 (877) 477-8633
Purpose
Topical Analgesic
Package Label Principal Display Panel
idocaine
MUSCLES • JOINTS
MAXIMUM STRENGTH
AVAILABLE WITHOUT A PRESCRIPTION*
4%
Lidocaine
NET WT. 3 OZ (85G
* Please review the disclaimer below.
