TheraICE Rx TM Lidocaine&Menthol Pain Relief Gel-Patch, 7 Patches

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]

PAIN RELIEF GEL-PATCH- lidocaine, menthol patch 
R & Y Group, LLC

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TheraICE Rx TM Lidocaine&Menthol Pain Relief Gel-Patch, 7 Patches

Active ingredient

Lidocaine 4.0% w/w ...... Purpose: Topical anesthetic

Menthol 1.0% w/w ...... Purpose: Topical analgesic

Purpose

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

For temporary relief of pain

Warnings

• Use only as directed
• For external use only
• Avoid contact with eyes
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

When using this product

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

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

Stop use and consult a doctor if

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

Adult 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

Inactive Ingredients

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

Other information

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

Package label. Principal display panel

PAIN RELIEF GEL-PATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83016-172
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.12 g  in 3 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 3 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)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83016-172-07	7 in 1 POUCH	10/26/2022	12/21/2023
1	NDC: 83016-172-01	3 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	10/26/2022	12/21/2023

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(83016-172)

Revised: 12/2023

Document Id: 0d00bbfb-a721-2bf1-e063-6394a90a0c71

34390-5

Set id: ebc923ff-3826-4def-e053-2995a90a1f72

Version: 2

Effective Time: 20231221