DRMITSUI LIDOCAINE 4% PAIN RELIEVING GEL- lidocaine patch

DRMITSUI Lidocaine 4% Pain Relieving Gel by

Drug Labeling and Warnings

DRMITSUI Lidocaine 4% Pain Relieving Gel by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ruyu Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Lidocaine 4% ----
PURPOSE
Topical analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRMITSUI LIDOCAINE 4% PAIN RELIEVING GEL 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85713-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
POLYVINYL ALCOHOL (UNII: 532B59J990)
TARTARIC ACID (UNII: W4888I119H)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
ALUMINUM SILICATE (UNII: T1FAD4SS2M)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85713-102-01	6 in 1 BOX	12/16/2025
1		10 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	12/16/2025

Labeler - Guangzhou Ruyu Cosmetics Co., Ltd (450563343)

Registrant - Guangzhou Ruyu Cosmetics Co., Ltd (450563343)