MEDIPAP COOL- l-menthol patch

Medipap Cool by

Drug Labeling and Warnings

Medipap Cool by is a Otc medication manufactured, distributed, or labeled by Cho-A Pharm.Co.,Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

L-Menthol (20mg/11.7g)

Purpose

External analgesic

Uses

For the temporarily relief of minor aches and pains of muscles and joints associated with:

• Arthritis
• Simple backache
• Strains
• Bruises
• Sprains

Directions

Adults and children 12 years of age and over:

• Clean and dry affected area
• Remove patch from film
• Apply to affected area no more than 3 to 4 times daily for 7 days
• Remove patch from skin after at most 8 hours’ application

Children undress 12 years of age: consult a doctor

Warnings

For external use only

Do not use

• on wounds or damaged skin
• if you are allergic to any ingredients of this product
• with a heating pad
• with, or at the same time as, other external analgesic products

When using this product

• do not use otherwise than directed
• avoid contact with eyes, mucous membranes or rashes
• do not bandage tightly

Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

Stop use and ask a doctor if

• rash, itching, or excessive skin irritation develops
• conditions worsen
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive ingredients

Felbinac, Methylparaben, Propylparaben, Diisopropanolamine, Dipropylene Glycol, Propylene Glycol Monolaurate, Conc. Glycerin, Titanium Oxide, Kaolin, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Sodium Polyacrylate, Gelatin, Carbomer Solution, Tartaric Acid, Ferric Oxide, Butylhydroxytoluene, Purified Water

Medipap Cool

INGREDIENTS AND APPEARANCE

MEDIPAP COOL 
l-menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58354-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	20 mg  in 11.7 g

Inactive Ingredients
Ingredient Name	Strength
FELBINAC (UNII: 94WNJ5U8L7)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 1200 MPA.S AT 1%) (UNII: 4J4P6L645M)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TARTARIC ACID (UNII: W4888I119H)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PROPYLENE GLYCOL MONOLAURATE (UNII: 668Z5835Z3)
KAOLIN (UNII: 24H4NWX5CO)
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58354-107-02	5 in 1 POUCH	02/21/2018
1	NDC: 58354-107-01	11.7 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
unapproved drug other		02/21/2018

Labeler - Cho-A Pharm.Co.,Ltd. (688056831)

Registrant - Cho-A Pharm.Co.,Ltd. (688056831)

Establishment
Name	Address	ID/FEI	Business Operations
Cho-A Pharm.Co.,Ltd.		688056831	manufacture(58354-107)