ZENOL COOL- methyl salicylate, l-menthol patch

ZENOL COOL by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Methyl salicylate

I-Menthol

INACTIVE INGREDIENT

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

PURPOSE

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

Arthritis Simple backache Strains Bruises Sprains

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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:

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

ZENOL COOL 
methyl salicylate, l-menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0026
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	140 mg  in 6.8 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	160 mg  in 6.8 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0026-1	6.8 g in 1 POUCH; Type 0: Not a Combination Product	10/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/01/2021

Labeler - Lydia Co., Ltd. (695735569)

Registrant - Lydia Co., Ltd. (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
Lydia Co., Ltd.		695735569	manufacture(72988-0026) , label(72988-0026)