TOPCARE PAIN RELIEF PATCH- lidocaine, menthol patch

TopCare Pain Relief Patch by

Drug Labeling and Warnings

TopCare Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Foshan Aqua Gel Biotech Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• more than 1 patch on your body at a time
• On cut, irritated, or swollen skin
• on puncture wounds
• For more than one week without consulting a doctor
• If you are allergic to any active or inactive ingredients
• if pouch is damaged or opened

When using this product

• use only as directed
• Read and follow all directions and warnings on this carton
• Do not allow contact with the eyes
• Do not use at the same time as other topical analgesics
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use
• Do not microwave
• dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and ask a doctor if

• condition worsens
• Redness is present
• Irritation develops
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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:

• clean and dry affected area
• carefully remove backing from patch starting at a corner.
• Appli sticky side of patch to affected area.
• Use one patch for up to 12 hours
• Dispatch patch after a single use.
• children under 12 years of age: consult a physician

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

INGREDIENTS AND APPEARANCE

TOPCARE PAIN RELIEF PATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-007-05	5 in 1 CARTON	01/01/2022
1		1 g in 1 POUCH; 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	01/01/2022

Labeler - Topco Associates LLC (006935977)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd		529128763	manufacture(76162-007)