Label: COOL PAP CATAPLASMA- methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol patch
- NDC Code(s): 72988-0008-1
- Packager: Lydia Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 29, 2019
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF 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.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
COOL PAP CATAPLASMA
methyl salicylate, l-menthol, dl-camphor, mentha oil, thymol patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72988-0008 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:72988-0008-1 17.5 g in 1 POUCH; 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(72988-0008) Establishment Name Address ID/FEI Business Operations Lydia Co., Ltd. 695735569 label(72988-0008)