HOT AND COLD LIDOCAINE WITH MENTHOL PATCH PAIN RELIEF- lidocaine and menthol patch

Hot and Cold Lidocaine with Menthol Patch by

Drug Labeling and Warnings

Hot and Cold Lidocaine with Menthol Patch by is a Otc medication manufactured, distributed, or labeled by DR SABHARWAL'S WOUND CARE, Velocity Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Lidocaine 4 %	Topical analgesic
Menthol 1%	Topical analgesic

Uses

Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.

Warnings

For external use only.

Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not apply to open wounds or sensitive skin
• do not bandage tightly or use a heating pad

Stop use and ask a doctor if

• excessive redness or irritation is present
• condition worsens
• pain persists for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of Reach of children. If swallowed, get medical help or contact a Poison control Center right away.

Directions

• adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
• children: consult your physician
• remove protective film, gently apply to affected area.

Inactive Ingredients

colloidal silicon dioxide, Kaolin, Polyacrylic acid, Sodium Polyacrylate, Polysorbate, Titanium Dioxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOT AND COLD LIDOCAINE WITH MENTHOL PATCH  PAIN RELIEF
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71318-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71318-001-25	1125 in 1 CASE	06/22/2017
1		1 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	03/03/2017

Labeler - DR SABHARWAL'S WOUND CARE (862184668)

Registrant - Velocity Pharma LLC (962198409)

Establishment
Name	Address	ID/FEI	Business Operations
DR SABHARWAL'S WOUND CARE		862184668	manufacture(71318-001)