Otc - Active Ingredient
Lidocaine 4% ----
PURPOSE
Topical analgesic
Drmitsui Lidocaine 4% Pain Relieving Gel Patch
FDA Label NDC 85713-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ruyu Cosmetics Co., Ltd for the product Drmitsui Lidocaine 4% Pain Relieving Gel (NDC 85713-102). 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 otc - active ingredient, otc - keep out of reach of children, otc - purpose, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Otc - Purpose
Uses for temporary relief of pain:
1.Fold sides back, pull apart to expose adhesive. 2.Place on affected area. 3.Peel off one side of the film. 4.Peel off the
remaining film.5.Press and smooth patch to secure.
Warnings
For external use only
Do not use:
1.More than 1 patch at atime. 2.0n wounds or damaged skin. 3.With a heating pad. 4.lf you are allergic to any ingredients
of this product.
Dosage & Administration
Apply 1 patch at a time
to affected area, not more than 3 to 4 times daily
Indications & Usage
Adults and children 12 years of age and over:
1. Clean and dry affected area. 2.Remove film from patch and apply to the skin (see illustration). 3.Apply 1 patch at a time
to affected area, not more than 3 to 4 times daily. 4.Remove patch from the skin after at most 8-hour application.
Inactive Ingredient
INACTIVE INGREDIENTS
ALUMINUM SILICATE, DIHYDROXYALUMINUM AMINOACETATE, DISODIUM EDETATE, GELATIN, GLYCERIN, METHYLPARABENOLEIC ACID, POLYACRYLIC ACID, POLYVINYL ALCOHOL, PROPYLENE GLYCOL, PROPYLPARABEN, SODIUM POLYACRYLATETARTARIC ACID, TITANIUM DIOXIDE, WATER
Package Label.Principal Display Panel
Labeling (Labeling 102 1)
* Please review the disclaimer below.
