BUMOOLY-S- methyl salicylate solution

Bumooly-S by

Drug Labeling and Warnings

Bumooly-S by is a Otc medication manufactured, distributed, or labeled by Scott Holdings Co., Ltd., Hyundai Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

methyl salicylate

INACTIVE INGREDIENT

camphor, menthol, glycyrrhetic acid, diphenhydramine hcl, dibucaine hcl

PURPOSE

aczema, dermatitis, erosion, miliaria, pruritus, pernio, insect bite, hives

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

apply to the affected area once to several times a day

WARNINGS

avoid contact with eyes, if this product splashes in to your eyes, wash immediately with water

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BUMOOLY-S 
methyl salicylate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68994-2001
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40)
DIBUCAINE HYDROCHLORIDE (UNII: Z97702A5DG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68994-2001-1	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/16/2014

Labeler - Scott Holdings Co., Ltd. (689665651)

Registrant - Scott Holdings Co., Ltd. (689665651)

Establishment
Name	Address	ID/FEI	Business Operations
Hyundai Pharmaceutical Co., Ltd.		687874958	manufacture(68994-2001)