COOL PAP CATAPLASMA- methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol gel 
Lydia Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Methyl salicylate

ℓ-Menthol

dl-Camphor

Mentha oil

Thymol

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

Topical Analgesic

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

keep out of reach of the children

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.

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

for external use only

label

COOL PAP CATAPLASMA 
methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0006
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL17.5 mg  in 17.5 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL87.5 mg  in 17.5 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL17.5 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 SALICYLATE262.5 mg  in 17.5 g
Inactive Ingredients
Ingredient NameStrength
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72988-0006-117.5 g in 1 PATCH; Type 0: Not a Combination Product03/29/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/23/2019
Labeler - Lydia Co., Ltd. (695735569)
Registrant - Lydia Co., Ltd. (695735569)
Establishment
NameAddressID/FEIBusiness Operations
Jeil Health Science Inc.689851513manufacture(72988-0006)
Establishment
NameAddressID/FEIBusiness Operations
Lydia Co., Ltd.695735569label(72988-0006)

Revised: 3/2019
Document Id: 852de335-db9c-1a7d-e053-2991aa0a45ef
Set id: 852dda0d-db03-bda6-e053-2a91aa0ac5ca
Version: 1
Effective Time: 20190328
 
Lydia Co., Ltd.