TheraICE LIDOCAINE&MENTHOL PAIN RELIEF, 5 Patches

Pain Relief by

Drug Labeling and Warnings

Pain Relief 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- lidocaine, menthol patch 
R & Y Group, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TheraICE LIDOCAINE&MENTHOL PAIN RELIEF, 5 Patches

Active ingredient

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

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

Purpose

Topical anesthetic (Lidocaine)

Topical analgesic (Menthol)

Uses

For temporary relieve 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 theskin
• 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 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83016-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.03 g  in 3 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.12 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: 83016-173-05	5 in 1 POUCH	10/13/2022	10/24/2022
1	NDC: 83016-173-01	3 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 not final	part348	10/13/2022	10/24/2022

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(83016-173)

Revised: 10/2022

Document Id: ebc92cee-ec7f-439f-e053-2a95a90a30de

34390-5

Set id: ea8531d3-285b-6b8f-e053-2a95a90a36e0

Version: 2

Effective Time: 20221024