TOPCARE PAIN RELIEF PATCH- lidocaine, menthol patch 
Topco Associates 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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TopCare Pain Relief Patch Lidocaine plus Menthol

Active ingredients

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

Use

for the temporary relief of pain

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Directions

adults and children 12 years of age and over:

Inactive ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.

Package/Label Principal Display Panel

label

TOPCARE PAIN RELIEF PATCH 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-007-055 in 1 CARTON01/01/2022
11 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2022
Labeler - Topco Associates LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd529128763manufacture(76162-007)

Revised: 1/2022
Document Id: d56a3a99-9bd6-68cc-e053-2a95a90a34fd
Set id: d4c89c4f-d69a-7786-e053-2995a90a71e7
Version: 2
Effective Time: 20220112
 
Topco Associates LLC