TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT PLUS MENTHOL 1PERCENT- lidocaine, menthol patch

Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent by

Drug Labeling and Warnings

Toplast Pain Relief Lidocaine 4percent plus Menthol 1percent 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 INGREDIENTS (in each patch)

Lidocaine 4%
Menthol 1%

INACTIVE INGREDIENTS

Glycerin, D-Sorbitol Solution, Propylene Glycol, Sodium Polyacrylate, Polyacrylic Acid, Urea, Carboxymethylcellulose Sodium, Gelatin, Kaolin, Titanium Oxide, Tartaric Acid, Dihydroxyaluminum Aminoacetate, Methylparaben, Polysorbate 80, Sorbitan Oleate, Disodium Edetate Hydrate, Propylparaben, Water

PURPOSE

Topical Anesthetic
Topical Analgesic

WARNINGS

For external use only
Safety Warning : Prior to using the product, conduct a skin patch test on your forearm to assess sensitivity and/or allergic reactions
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Do not use
■ More than 1 patch on your body at a time ■ On the cut, irritated, swollen or puncture wounds ■ For more than one week without consulting a doctor
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Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients
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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 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 ■ Make sure to dispose the used patch away from children and pets, as used ones still contain the drug that can cause serious adverse effects on them if they chew or ingest the patch
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Stop use and ask a doctor if
■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or recur ■ Skin swells or blisters where the product was applied
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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

Keep out of reach of children and pets

If swallowed, get medical help or contact a Poison Control Center right away

Uses

For temporary relief of minor pain

Directions

Adult and children 12 years of age and over :
■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch at a time and do not use for more than 12 hours
Children under 12 years of age : consult a physician

Other Information

■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

Questions or Comments

■ Visit us at : icure.co.kr/en ■ Contact us : icurepharm@icure.co.kr

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPLAST PAIN RELIEF LIDOCAINE 4PERCENT PLUS MENTHOL 1PERCENT 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73279-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	Lidocaine	240 mg
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	60 mg

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
Propylene Glycol (UNII: 6DC9Q167V3)
Urea (UNII: 8W8T17847W)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
Gelatin (UNII: 2G86QN327L)
Kaolin (UNII: 24H4NWX5CO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Tartaric Acid (UNII: W4888I119H)
Dihydroxyaluminum Aminoacetate (UNII: DO250MG0W6)
Methylparaben (UNII: A2I8C7HI9T)
Polysorbate 80 (UNII: 6OZP39ZG8H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73279-0004-2	5 in 1 CARTON	07/01/2020
1	NDC: 73279-0004-1	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 not final	part348	07/01/2020

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(73279-0004)