ZENOL COOL- methyl salicylate poultice

Zenol Cool by

Drug Labeling and Warnings

Zenol Cool by is a Otc medication manufactured, distributed, or labeled by Green Cross Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

methyl salicylate

INACTIVE INGREDIENT

l-menthol, dl-camphor, thymol, diphenhydramine hydrochloride, titanium oxide, kaolin, carboxymethylcellulose sodium, sodium polyacrylate, dired aluminum hydroxide gel, disodium edetate hydrate, gelatin, tartaric acid, polysorbate 80, sorbitan sesquioleate, nikazole TS-620, concentrated glycerin, borneol-p, rose incense, purified water, nonwoven fabric, polypropylene film

PURPOSE

for the temporary relief of sore muscles, sprains, bruises, shoulder pain, arthralgia, backache, neuralgia, rheumatic pain and fracture pain

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

step 1:  remove the colored protective sheet from the adhesive tape strip
step 2: attach the cotton side of Zenol medicated patch to the adhesive tape
step 3: remove the transparent protective film from the patch, and also the remainder of the colored protective sheet (the two strips with arrows on the side)
step 4: apply one or twice daily or as needed, to the affected skin surface
step 5: following the use, tightly close and fold the open end of the pack, in order to preserve the efficacy of the remaining patch

WARNINGS

1. while skin irritations such as redness, eruption, or itchiness are uncommon, but if they would occur, discontinue usage and consult a physician or a pharmacist
2. if painful symptoms do no improve after application for several days, discontinue usage and consul with a physician or a pharmacist

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZENOL COOL  
methyl salicylate poultice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61476-100
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	160 mg  in 17 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61476-100-01	17 g in 1 PATCH; Type 0: Not a Combination Product	11/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/23/2013

Labeler - Green Cross Corp (687760561)

Establishment
Name	Address	ID/FEI	Business Operations
Green Cross Corp		689852033	manufacture(61476-100)