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

  • TEMPORARILY RELIEVES MINOR ACHES, MUSCLES AND JOINT PAINS DUE TO:
  • SIMPLE BACKACHE
  • ARTHRITIS
  • STRAINS
  • SPRAINS
  • BRUISES

  • WARNINGS
  • EXTERNAL USE ONLY
  • USE ONLY AS DIRECTED

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_Box_3mL_Single_2012-10-16Pain Reliever Oil ART_Box_40mL_Single_2012-10-16

HYSAN PAIN RELIEVER 
methyl salicylate, menthol, camphor (synthetic), eucalyptus oil oil
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:63255-021
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 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63255-021-023 mL in 1 BOTTLE
2NDC:63255-021-0140 mL in 1 BOTTLE
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/FEIBusiness Operations
HYSAN PHARMACEUTICAL CO LTD666427133manufacture(63255-021)

Revised: 10/2012
Document Id: cba5e7ef-6628-40d2-8f84-ff5c4bbfdf1b
Set id: cc6f6479-1a3c-4506-8ef9-c37d8c598e1f
Version: 2
Effective Time: 20121029
 
HYSAN PHARMACEUTICAL CO LTD