FDA.reportPublic FDA data

Hua Tuo Huo Lu Oil

Manufacturer
Hysan Pharmaceutical Co Ltd
Effective date
2019-09-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:12:46

Label at a glance#

ProductHua Tuo Huo Lu Oil
Active ingredientMETHYL SALICYLATE, MENTHOL, CAMPHOR (SYNTHETIC)
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Methyl Salicylate 40%

Menthol 36%

Camphor 10%

OTC - PURPOSE SECTION

Purpose:

External Analgesic

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves minor aches, 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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Eucalyptus Oil, Turpentine Oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HuaTuo_HuoLuOil_50mLHuaTuo_HuoLuOil_50mL

HuaTuo_HuoLuOil_3mLHuaTuo_HuoLuOil_3mL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET4
MENTHOLACTIVE INGREDIENTL7T10EIP3A4
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y4
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET4
MENTHOLACTIVE MOIETYL7T10EIP3A4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6624
TURPENTINE OILINACTIVE INGREDIENTC5H0QJ6V7F4

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63255-01163255-011-01, 63255-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
EUCALYPTUS OIL2R04ONI662IACT
TURPENTINE OILC5H0QJ6V7FIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate

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
8f38d095-89f7-4457-91fb-d5198dce13225e33d300-c71f-4f0c-8f5b-2a55d4a6ca1d2019-09-10WarningsExact identifier
spl id: 8f38d095-89f7-4457-91fb-d5198dce1322
spl set id: 5e33d300-c71f-4f0c-8f5b-2a55d4a6ca1d

Reported adverse events (FAERS/openFDA)#

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