PAIN RELIEVEING GEL-PATCH- lidocaine patch

Pain Relieveing Gel-Patch by

Drug Labeling and Warnings

Pain Relieveing Gel-Patch by is a Otc medication manufactured, distributed, or labeled by Bullet point LLC, Bullet Point LLC, ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Adults and children 12 years old and over:

• Clean and dry the affected area.
• Apply 1 patch to the affected area.
• Do not exceed 1 patch at a time.
• Leave in place for up to 8 hours.
• Do not use more than 1 patch in 24 hours unless directed by a doctor.
  
  Children under 12 years old: ask a doctor.

WARNINGS

For external use only

INACTIVE INGREDIENT

Dihydroxyaluminum Aminoacetate, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

INDICATIONS & USAGE

For temporary relief of pain.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact Poison Control.

PURPOSE

Topical anesthetic.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVEING GEL-PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84008-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
TARTARIC ACID (UNII: W4888I119H)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POVIDONE K90 (UNII: RDH86HJV5Z)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84008-001-02	30 in 1 BOX	11/03/2025
1	NDC: 84008-001-01	12 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	11/03/2025

Labeler - Bullet point LLC (118190100)

Registrant - Bullet Point LLC (118190100)

Establishment
Name	Address	ID/FEI	Business Operations
ShanghaiChuangshiMedicalTechnology(Group)Co.,Ltd.		546872672	manufacture(84008-001) , label(84008-001)