PAIN RELIEF GEL-PATCH- 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 TM Lidocaine&Menthol Pain Relief Gel-Patch, 7 Patches

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

When using this product

Stop use and consult a doctor if

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.

Children under 12 years of age: Consult a physician

Other Information

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

0107

PAIN RELIEF GEL-PATCH 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83016-171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.12 g  in 12 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.48 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83016-171-077 in 1 POUCH06/15/2023
1NDC:83016-171-0112 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/2023
Labeler - R & Y Group, LLC (968585765)
Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
Establishment
NameAddressID/FEIBusiness Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(83016-171)

Revised: 6/2023
Document Id: fe0478d8-2f07-cd56-e053-6294a90a58e5
Set id: fe0478d8-2f06-cd56-e053-6294a90a58e5
Version: 1
Effective Time: 20230615
 
R & Y Group, LLC