LIDOCAINE PATCH- lidocaine 4% menthol 1% patch

Lidocaine Patch by

Drug Labeling and Warnings

Lidocaine Patch by is a Otc medication manufactured, distributed, or labeled by Anhui Miao De Tang Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

LIDOCAINE PATCH

Active Ingredient(s)

LIDOCAINE 4% Purpose:Topical Analgesic

MENTHOL 1% Purpose: External Analges

Purpose

Topical Anesthetic, External Analges, LIDOCAINE PATCH

Use

LIDOCAINE PATCH to help Temporarily relteves minor pain

Warnings

For external use only. Flammable.

Do not use

More than one patch on your body at a time or on cut, irritated or swollen skin
On open or puncture wounds

For more than one week without consulling a doctor.

WHEN USING

Use only as directed. Read and邸ow all directions and warnings on this label.
Rare cases of serious burns have been reported with products of this type.
Oo not apply to wou心s or damaged, broken or irritated skin
Do not allow contact with the eyes and mucous membranes.
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 producl 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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Adults and children over 12 years:

Wash and dry the affected area.
Remove backing from patch by firmty grasping both ends and gently pulling until backing separates in the middle

Carefully remove smaller portion of back,ng from patch and apply exposed portion of patch to a什ected area
Once exposed portion of patch is po奾oned.carefully remove remaining backing tocomplelely apply patch to affected area.
Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
Use only 1 patch for a maximum of 24 hours.

Other information

• Store at room temperature - do not exceed 86'F, 30'C

Inactive ingredients

aluminum glycinate, glycerin, sodium polyacrylate. tartaric acid, DMOM hydantoin, water

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

LIDOCAINE PATCH 
lidocaine 4% menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81484-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.4 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TARTARIC ACID (UNII: W4888I119H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81484-301-02	6 in 1 BOX	11/01/2021
1	NDC: 81484-301-01	1 in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/01/2021

Labeler - Anhui Miao De Tang Pharmaceutical Co., Ltd. (405744102)

Establishment
Name	Address	ID/FEI	Business Operations
Anhui Miao De Tang Pharmaceutical Co., Ltd.		405744102	manufacture(81484-301)