FDA.reportPublic FDA data

Tiger Balm

Manufacturer
Haw Par Healthcare Ltd. | OLIC (Thailand) Ltd.
Effective date
2025-02-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:54:24

Label at a glance#

ProductTiger Balm Pain Relieving Muscle
Active ingredientMethyl Salicylate, Menthol, Unspecified Form, Camphor (Synthetic)
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.

Dosage and administration

For adults and children over 12 years of age, spray on the affected area. Repeat 3 to 4 times daily For children 12 years of age or younger, consult a doctor before use Shake well before use. Point spray towards area to be treated. Spray in short bursts about 6 inches from the skin. The product is quickly absorbed, but may be rubbed in after spraying if desired.

Storage and handling

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use This product may cause allergic reaction on some individuals. Test on small area before use Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients (w/w)Purpose
Methyl Salicylate 25%Topical Analgesic
Menthol 16%Topical Analgesic
Camphor 7%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, bruises, strains and sprains.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with wrap or use heating pad
  • Do not use 1 hour prior to bathing or within 30 minutes after bathing
  • Avoid inhalation
  • Do not use in confined space.

Flammable

SPL UNCLASSIFIED SECTION

  • Do not use near heat or flame or while smoking
  • Avoid long term storage above 104°F (40°C)
  • Do not puncture or incinerate. Contents under pressure
  • Do not store at temperatures above 120°F (49°C).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days
  • Pain clears up and then recurs a few days later.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, or if you have sensitive skin, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For adults and children over 12 years of age, spray on the affected area. Repeat 3 to 4 times daily
  • For children 12 years of age or younger, consult a doctor before use
  • Shake well before use. Point spray towards area to be treated. Spray in short bursts about 6 inches from the skin. The product is quickly absorbed, but may be rubbed in after spraying if desired.

Other Information

STORAGE AND HANDLING SECTION

  • Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult doctor before use
  • This product may cause allergic reaction on some individuals. Test on small area before use
  • Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethanol (Dehydrated Alcohol), Liquefied Petroleum Gas.

Questions

OTC - QUESTIONS SECTION

(925) 292-3888

SPL UNCLASSIFIED SECTION

Manufactured by OLIC (Thailand) Limited for Haw Par Healthcare Ltd., Singapore under licence from Haw Par Corporation Ltd.

PRINCIPAL DISPLAY PANEL - 75 ml Canister Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TIGER BALM®

NDC 66761-327-75

ACTIVE

Pain Relieving
MUSCLE
SPRAY

  • EASY-TO-APPLY
  • FOR HARD TO REACH
    AREAS

NET 2.53 Fl. Oz. (75ml)

PRINCIPAL DISPLAY PANEL - 75 ml Canister Carton
PRINCIPAL DISPLAY PANEL - 75 ml Canister Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2047884camphor 7 % / menthol 16 % / methyl salicylate 25 % Topical SprayPSN5
2047884camphor 70 MG/ML / menthol 160 MG/ML / methyl salicylate 250 MG/ML Topical SpraySCD5
2047884camphor 7 % / menthol 16 % / methyl salicylate 25 % Topical SpraySY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66761-327-75Tiger Balm Pain Relieving Muscle1 in 1 CARTONSPRAY15
66761-327-75Tiger Balm Pain Relieving Muscle75 mL in 1 CANISTERSPRAY755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66761-327TIGER BALM PAIN RELIEVING MUSCLE (METHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)) SPRAY [HAW PAR HEALTHCARE LTD.]5Current NDC, Legacy NDC, 2 package rows20250206_96b06d3f-8685-4314-ad7d-5d2720f4dde6.zip

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
66761-32766761-327-75

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
Menthol, Unspecified FormL7T10EIP3AACTIB
Camphor (Synthetic)5TJD82A1ETACTIB
Alcohol3K9958V90MIACT
Liquefied Petroleum Gas5K616HU99VIACT

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
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
ndc (package): 66761-327-75
ndc (product): 66761-327
ndc11 (package): 66761032775
spl id: d8b51f84-42b4-41ff-9c67-bc23c65a96c7
spl set id: 96b06d3f-8685-4314-ad7d-5d2720f4dde6

Reported adverse events (FAERS/openFDA)#

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