LIDOCAINE 4% PLUS MENTHOL 1%- lidocaine, menthol patch

Lidocaine 4% plus Menthol 1% by

Drug Labeling and Warnings

Lidocaine 4% plus Menthol 1% by is a Otc medication manufactured, distributed, or labeled by Icure Pharmaceutical Inc, Wanju Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

lidocaine, menthol

INACTIVE INGREDIENT

Methylparaben, Propylparaben, Sodium Polyacrylate, Polyacrylic Acid 20% Solution, Gelatin, Carboxymethyl Cellulose, Titanium Oxide, Kaolin, Dihydroxyaluminium Aminoacetate, Concentrated Glycerin, D-Sorbitol Solution, Urea, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Tartaric Acid, Propylene Glycol, Purified Water

PURPOSE

Temporary relief of minor pain

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Use only as directed. Read and follow all directions and warnings on this label.
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 product away from children and pets
Used patch still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests patch

WARNINGS

- Warnings
For external use only.
Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients.

- 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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIDOCAINE 4% PLUS MENTHOL 1% 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73279-0001
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
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73279-0001-2	5 in 1 POUCH	08/31/2019
1	NDC: 73279-0001-1	6 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 not final	part348	08/31/2019

Labeler - Icure Pharmaceutical Inc, Wanju Factory (695687612)

Registrant - Icure Pharmaceutical Inc, Wanju Factory (695687612)

Establishment
Name	Address	ID/FEI	Business Operations
Icure Pharmaceutical Inc, Wanju Factory		695687612	manufacture(73279-0001) , label(73279-0001)