BUMOOLY-S - methyl salicylate solution
Scott Holdings 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

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

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

keep out or reach of the children

apply to the affected area once to several times a day

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

for external use only

BUMOOLY-S
methyl salicylate solution

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

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

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

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

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

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

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

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

Revised: 5/2014

Document Id: 05999698-c1da-4f28-a82e-1ca80271eb8c

Set id: bdc48a36-d6da-4ecf-a2a7-fe9ef9049f00

Version: 1

Effective Time: 20140516

Scott Holdings Co., Ltd.