ZENOL COOL- methyl salicylate, l-menthol patch 
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

I-Menthol

Kaolin,Zine Oxide,Titanium Oxide,Galatin,Glycerin,Liquid Paraffin,Polybutene,Sodium Polyacrylate,Rubber Latex,Purified Water

For temporary relief of minor aches & pains of muscles & joints Associated with:

• Arthritis •Simple backache •Strains •Bruises •Sprains

keep out of reach of the children

Adults and children 12 years of age and over:

•Clean and dry affected area •Remove patch from film

•Apply to affected area not more than 3 to 4 times daily

•Remove patch from the skin after at most 8-hour application

Children under 12 years of age:

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

ZENOL COOL 
methyl salicylate, l-menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72988-0026
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL140 mg  in 6.8 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE160 mg  in 6.8 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72988-0026-16.8 g in 1 POUCH; Type 0: Not a Combination Product10/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/01/2021
Labeler - Lydia Co., Ltd. (695735569)
Registrant - Lydia Co., Ltd. (695735569)
Establishment
NameAddressID/FEIBusiness Operations
Lydia Co., Ltd.695735569manufacture(72988-0026) , label(72988-0026)

Revised: 7/2023
Document Id: ffcad475-c7fb-fb65-e053-6294a90a7e12
Set id: ce8817f1-4589-56df-e053-2a95a90a3bcd
Version: 3
Effective Time: 20230706
 
Lydia Co., Ltd.