FDA.reportPublic FDA data

HYSAN HUA TUO HUO LU

Manufacturer
HYSAN PHARMACEUTICAL CO LTD
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:49

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

HTHL50cc_MIC_2021HTHL50cc_MIC_2021

HTHL3cc_MIC_2021HTHL3cc_MIC_2021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1860084camphor 10 % / methyl salicylate 37 % Topical OilPSN2
1860084camphor 100 MG/ML / methyl salicylate 370 MG/ML Topical OilSCD2
1860084camphor 10 % / methyl salicylate 37 % Topical OilSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63255-123-01HYSAN HUA TUO HUO LU50 mL in 1 BOTTLE, GLASSOIL502
63255-123-02HYSAN HUA TUO HUO LU3 mL in 1 BOTTLE, GLASSOIL32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63255-123HYSAN HUA TUO HUO LU (METHYL SALICYLATE, CAMPHOR (SYNTHETIC)) OIL [HYSAN PHARMACEUTICAL CO LTD]2Current NDC, Legacy NDC, 2 package rows20241008_cd2288c4-9909-43c1-91da-b15545b09788.zip

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
63255-12363255-123-01, 63255-123-02

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
HYSAN HUA TUO HUO LUMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDcd2288c4-9909-43c1-91da-b15545b097882024-10-04WarningsExact identifier
ndc (package): 63255-123-02
ndc (package): 63255-123-01
ndc (product): 63255-123
ndc11 (package): 63255012302
ndc11 (package): 63255012301
spl id: b84f91ea-9b04-49c1-b5da-42dd248f93e8
spl set id: cd2288c4-9909-43c1-91da-b15545b09788

Reported adverse events (FAERS/openFDA)#

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