PAIN RELIEF GEL-PATCH- lidocaine, menthol patch

Pain Relief Gel-Patch by

Drug Labeling and Warnings

Pain Relief Gel-Patch by is a Otc medication manufactured, distributed, or labeled by R & Y Group, LLC, Shanghai Chuangshi Medical Technology (Group) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine 4% w/w ...... Purpose: Topical Anesthetic

Menthol 1% w/w ...... Purpose: Topical Analgesic

Purpose

Topical Anesthetic (Lidocaine)

Topical Analgesic (Menthol)

Use

for temporary relief of pain

Warnings

For External Use Only

Do not use

• More than 1 patch at a time
• If you are allergic to any ingredients of this product
• On wounds or damaged skin
• In large quantities, particularly over raw surfaces or blistered areas

When using this product

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes
• Do not bandage tightly

Stop use and consult a doctor if

• Localized skin reactions occur, such as a rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms clear up and occur again within a few days
• Symptoms persist for more than 7 days

If pregnant or breast-feeding,

ask a physician 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 12 years of age and over.

• Clean and dry affected area
• Remove film from patch and apply to the skin
• Apply to affected area not more than 3 to 4 times daily
• Remove patch from the skin after 8-hour application at most

Children under 12 years of age: Consult a physician

Other Information

• Store at 68° - 77° F (20° - 25° C)
• Store in a cool dry place away from direct sunlight

Inactive Ingredients

Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral Oil, Polyacrylic Acid, Polysorbate 80, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide, Water

Package label. Principal display panel

INGREDIENTS AND APPEARANCE

PAIN RELIEF GEL-PATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83016-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.12 g  in 12 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.48 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POVIDONE K90 (UNII: RDH86HJV5Z)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83016-171-07	7 in 1 POUCH	06/15/2023
1	NDC: 83016-171-01	12 g in 1 PACKET; 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	06/15/2023

Labeler - R & Y Group, LLC (968585765)

Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	manufacture(83016-171)