Lidocaine 4% Plus Manthol 1% Patch 24 Hours

Lidocaine Patch by

Drug Labeling and Warnings

Lidocaine Patch by is a Otc medication manufactured, distributed, or labeled by SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIDOCAINE PATCH- lidocaine 4% menthol 1% patch 
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS

----------

Lidocaine 4% Plus Manthol 1% Patch 24 Hours

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Menthol 1%   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

For temporary relief of minor pain.

Dosage and Administration

Directions: Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Discard patch after single use. Do not expose area to heat.

Children under 12 years of age: Consult a physician.

Warnings

For external use only.

Do not use

■ if you are allergic to any active or inactive ingredients of this product

■ on wounds or damaged, irretated, or sensitive skin

■ with any other topical anesthetic

■ for more than one week without consulting a doctor

■ with a heating pad

■ if pouch is damaged or open

When using this product

■ do not allow contact with the eyes

■ use only as directed, read and follow all directions and warnings on this package

■ do not bandage tightly or apply local heat

■ Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

■ do not reuse patch

Stop use and ask a doctor if

■ symptoms persist for more than seven days or clear up and occur again within a few days

■ condition worsens

■ localized skin reactions occur such as rash, pain, itching, redness, irritation, swelling or blistering.

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

Keep out of reach of children and pets.

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

Other Safety Information

Store in a clean, dry place outside of direct sunlight.  Store in original unopened pouch protected from moisture.

Inactive Ingredients

alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

Questions

Questions? 1-866-760-6565, Monday - Friday 8:30 a.m - 4:30 p.m. EST

Manufactured for:
AUM Pharmaceuticals
Hauppauge, NY 11788

Made in USA From Domestic and Imported Components

LIDOCAINE PATCH 
lidocaine 4% menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73317-6863
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (STYRENE/ISOPRENE 15/85) (UNII: 1SSZ6HXE7P)
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73317-6863-5	15 in 1 CARTON	07/02/2021
1		9 g 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 Drug	M015	07/02/2021	08/23/2024

Labeler - SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS (081225162)

Revised: 8/2024

Document Id: 16dee62b-544e-4ab9-ab77-fdc2fed255a5

34390-5

Set id: aa090bc7-bcdb-4ecf-8071-e17f61952f70

Version: 2

Effective Time: 20240829

 

SLV PHA