SINSINPAP COOL- levomenthol, thymol, camphor, mentha, eucalyptus patch

SINSINPAP COOL by

Drug Labeling and Warnings

SINSINPAP COOL by is a Otc medication manufactured, distributed, or labeled by Sinsin Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

L-Menthol 49.4 mg

Thymol 16.5 mg

DL-Camphor 82.4 mg

Mentha Oil 164.7 mg

Eucalyptus Oil 16.5 mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

• muscular pain
• joint pain
• backache
• bruise
• sprain
  

Warnings

For external use only

When using this product:

• use only as directed
• do not bandage tightly or use with a healing pad
• avoid contact with the eyes and mucous membranes
• do not apply to wounds or damaged skin

Stop use and ask a doctor if

• conditions worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• skin irritation develops

Keep out of reach of children.

If swallowed, get medical help from hospital right away

Directions

• Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.
• Children under 12 years of age: do not use, consult a doctor
• For easy application: partially peel back protective film and apply exposed patch to the site of pain.
• Carefully remove remaining film while pressing patch to skin for secure adhesion.

Storage condition

• avoid storing product in direct sunlight
• store at room temperature

Inactive ingredients

BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

Manufactured by:

SINSIN PHARM. CO., LTD.

Distributed by SS Pharmed USA

Made in Korea

NDC # : 55264-012-01

Principal Display Panel

INGREDIENTS AND APPEARANCE

SINSINPAP COOL 
levomenthol, thymol, camphor, mentha, eucalyptus patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55264-012
Route of Administration	TOPICAL, CUTANEOUS, TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	49.4 mg
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	16.5 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	82.4 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	164.7 mg
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	16.5 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITOL (UNII: 506T60A25R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
SILODRATE (UNII: 9T3UU8T0QK)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-4 STEARATE (UNII: J33E8608YN)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
TARTARIC ACID (UNII: W4888I119H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55264-012-05	1 in 1 CARTON	05/30/2016
1		5 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	05/30/2016

Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)

Registrant - Sinsin Pharmaceutical Co., Ltd. (823149161)