COOL PAP CATAPLASMA- methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol gel

Cool Pap Cataplasma by

Drug Labeling and Warnings

Cool Pap Cataplasma by is a Otc medication manufactured, distributed, or labeled by Lydia Co., Ltd., Jeil Health Science Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Methyl salicylate

ℓ-Menthol

dl-Camphor

Mentha oil

Thymol

INACTIVE INGREDIENT

Kaolin

Zinc oxide

Titanium oxide

Gelatin

Glycerin

Liquid paraffin

Carboxymethylcellulose sodium

Polybutene

Sodium polyacrylate

Butylated hydroxy toluene

Polysorbate 60

Methoxyethylene maleicanhydride copolymer

Citric acid hydrate

Natural rubber latex

Purified water

Nonwoven fabric

Polyester film

PURPOSE

Topical Analgesic

Temporarily relieves minor pain associated with - muscular pain - joint pain - backache - bruise - sprain

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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.

WARNINGS

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL PAP CATAPLASMA 
methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0006
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	17.5 mg  in 17.5 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	87.5 mg  in 17.5 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	17.5 mg  in 17.5 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	122.5 mg  in 17.5 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	262.5 mg  in 17.5 g

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0006-1	17.5 g in 1 PATCH; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/23/2019

Labeler - Lydia Co., Ltd. (695735569)

Registrant - Lydia Co., Ltd. (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
Jeil Health Science Inc.		689851513	manufacture(72988-0006)

Establishment
Name	Address	ID/FEI	Business Operations
Lydia Co., Ltd.		695735569	label(72988-0006)