LIDOCAINE DRY PATCH PLUS MENTHOL- lidocaine 4% and menthol 1% patch

Lidocaine Dry Patch Plus Menthol by

Drug Labeling and Warnings

Lidocaine Dry Patch Plus Menthol by is a Otc medication manufactured, distributed, or labeled by SAFREL PHARMACEUTICALS, LLC, DR. SABHARWAL'S WOUND CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Menthol 1%

Purpose

Topical Anesthetic

Uses

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

Warning

For external use only

Do not Use

• more than 1 patch on your body at a time or on cut, irritated or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor

When Using This Product

• use only as directed. Read and follow all directions and warnings on this label.
• do not allow contact with the eyes
• do not bandage tightly or apply local heat (such as heating pads) to the area of use
• do not use at the same time as other topical analgesics
• dispose of used patch in manner that always keeps product away from children or 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 right away.

Directions:

Adults and children over 12 years:

• clean and dry affected area
• remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
• carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
• once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
• use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

kaolin, polysorbate 80, polyacrylic acid, silicon dioxide, sodium polyacrylate, titanium dioxide

Package / Principle Label

Package / Inner Pouch

INGREDIENTS AND APPEARANCE

LIDOCAINE DRY PATCH PLUS MENTHOL 
lidocaine 4% and menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71309-915
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)

Product Characteristics
Color	white	Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71309-915-05	5 in 1 BOX	03/15/2022
1		1 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 final	part346	03/15/2022

Labeler - SAFREL PHARMACEUTICALS, LLC (080566287)

Registrant - SAFREL PHARMACEUTICALS, LLC (080566287)

Establishment
Name	Address	ID/FEI	Business Operations
DR. SABHARWAL'S WOUND CARE		862184668	manufacture(71309-915)