HYSAN PAIN RELIEVER - methyl salicylate, menthol, camphor (synthetic) and eucalyptus oil oil 
HYSAN PHARMACEUTICAL 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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ACTIVE INGREDIENT:

METHYL SALICYLATE 37%

MENTHOL 36%

CAMPHOR 10%

EUCALYPTUS OIL 10%

PURPOSE:

EXTERNAL ANALGESIC

STOP USE AND ASK A DOCTOR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

ADULTS AND CHILDREN 12 YEARS AND OLDER, APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.

CHILDREN UNDER 12 YEARS OF AGE CONSULT A DOCTOR.

INACTIVE INGREDIENTS:

TURPENTINE OIL, SPIKE LAVENDER OIL, PERFUME OIL

Pain Reliever Oil ART_LBL_40mL_For singlePain Reliever Oil ART_LBL_40mL_For 12-packPain Reliever Oil ART_Box_40mL_SinglePain Reliever Oil ART_Box_3mL_Single

Hysan

Pain Reliever Oil


HYSAN PAIN RELIEVER 
methyl salicylate, menthol, camphor (synthetic), eucalyptus oil oil
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63255-020
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) SALICYLIC ACID37 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL36 g  in 100 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)10 g  in 100 mL
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TURPENTINE OIL 
LAVENDER OIL 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:63255-020-511 BOTTLE in 1 BOXcontains a BOTTLE (63255-020-11)
1NDC:63255-020-113 mL in 1 BOTTLEThis package is contained within the BOX (63255-020-51)
2NDC:63255-020-521 BOTTLE in 1 BOXcontains a BOTTLE (63255-020-12)
2NDC:63255-020-1240 mL in 1 BOTTLEThis package is contained within the BOX (63255-020-52)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/20/2012

Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)
Establishment
NameAddressID/FEIOperations
HYSAN PHARMACEUTICAL CO LTD666427133manufacture

Revised: 09/2012 HYSAN PHARMACEUTICAL CO LTD