HYSAN HUA TUO HUO LU- methyl salicylate, camphor (synthetic) 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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Drug Facts

Active Ingredients

Methyl Salicylate 37%

Camphor 10%

Purpose

External Analgesic

Uses

Temporarily relieves minor aches, pains of muscles and joint pains due to:

warnings

Do not use

When using this product

Stop use and ask a doctor if

if pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients

menthol, turpentine oil, eucalyptus oil, lavender oil, tolu balsam

Question or comments?

(626) 354 1819 M-F 9am to 5pm

HTHL50cc_MIC_2021

HTHL3cc_MIC_2021

HYSAN HUA TUO HUO LU 
methyl salicylate, camphor (synthetic) oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63255-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE37 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A)  
TURPENTINE OIL (UNII: C5H0QJ6V7F)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
TOLU BALSAM (UNII: TD2LE91MBE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63255-123-0150 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/18/2021
2NDC:63255-123-023 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product02/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/18/2021
Labeler - HYSAN PHARMACEUTICAL CO LTD (666427133)
Establishment
NameAddressID/FEIBusiness Operations
HYSAN PHARMACEUTICAL CO LTD666427133manufacture(63255-123)

Revised: 2/2021
Document Id: 51a196db-1fab-4f66-9b61-ee07b16ca92b
Set id: cd2288c4-9909-43c1-91da-b15545b09788
Version: 1
Effective Time: 20210218
 
HYSAN PHARMACEUTICAL CO LTD