FDA.reportPublic FDA data

HYSAN HUA TUO HUO LU

Manufacturer
HYSAN PHARMACEUTICAL CO LTD
Effective date
2022-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:57:20

Label at a glance#

ProductHYSAN HUA TUO HUO LU
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Drug Facts

Active Ingredients

​Methyl Salicylate 37%

Camphor 10%

OTC - PURPOSE SECTION

​Purpose

​External Analgesic

INDICATIONS & USAGE SECTION

​Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

WARNINGS SECTION

​warnings​

  • external use only
  • use only as directed

OTC - DO NOT USE SECTION

​Do not use​

  • on opened wounds
  • on damaged skin

OTC - WHEN USING SECTION

​When using this product​

  • avoid contact with the eyes
  • do not bandage tighly

OTC - STOP USE SECTION

​Stop use and ask a doctor if​

  • a rash or irritation develops
  • condition worsens
  • symptoms persist for more than 7 days or clears up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

​Directions​

  • adults and children 12 years and older, clean and dry the affected area, apply and massage gently not more than 3 to 4 times daily
  • children under 12 years of age, consult a doctor before using

OTHER SAFETY INFORMATION

Other information​

  • be stored below 28°C (82°F)
  • closed tightly after used

INACTIVE INGREDIENT SECTION

Inactive ingredients​

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

OTC - QUESTIONS SECTION

Question or comments?​

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HT_HL_50_NF_2017HT_HL_50_NF_2017HT_HL_3_NF_2017HT_HL_3_NF_2017

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63255-12163255-121-01, 63255-121-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AIACT
TURPENTINE OILC5H0QJ6V7FIACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
TOLU BALSAMTD2LE91MBEIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3bd2d901-d17a-45f0-80cf-614c13501f9e8ca80429-57dd-4e14-8334-cae87f55b8362022-07-09WarningsExact identifier
spl id: 3bd2d901-d17a-45f0-80cf-614c13501f9e
spl set id: 8ca80429-57dd-4e14-8334-cae87f55b836

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.