FDA.reportPublic FDA data

Tiger Balm

Manufacturer
Haw Par Healthcare Ltd. | Tiger Balm (Malaysia) Sdn. Bhd.
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:37:23

Label at a glance#

ProductTiger Balm
Active ingredientMethyl Salicylate, Menthol, Unspecified Form
Label structure10 sections

Indications and uses

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

Dosage and administration

For adults and children over 12, rub well on the affected area. Repeat 3-4 times daily For children 12 years of age or younger, consult a doctor before use

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Methyl Salicylate 28%Topical Analgesic
Menthol 16%Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

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.

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, rub well on the affected area. Repeat 3-4 times daily
  • For children 12 years of age or younger, consult a doctor before use

Other Information

STORAGE AND HANDLING SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Eucalyptus Oil, Spike Lavender Oil, Light Mineral Oil.

Questions

OTC - QUESTIONS SECTION

(925) 292-3888

SPL UNCLASSIFIED SECTION

Manufactured by Haw Par Healthcare
Ltd., Singapore under licence from Haw
Par Corporation Ltd.

PRINCIPAL DISPLAY PANEL - 57 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66761-333-22

TIGER BALM®

LINIMENT

PAIN RELIEVING LINIMENT
NON-STAINING

2 FL.OZ. 57ml

PRINCIPAL DISPLAY PANEL - 57 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 57 ml Bottle Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
849499menthol 16 % / methyl salicylate 28 % Topical LinimentPSN6
849499menthol 160 MG/ML / methyl salicylate 280 MG/ML Topical SolutionSCD6
849499menthol 16 % / methyl salicylate 28 % Topical LinimentSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66761-333-22Tiger Balm57 mL in 1 BOTTLELINIMENT576
66761-333-22Tiger Balm1 in 1 BOXLINIMENT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66761-333TIGER BALM (METHYL SALICYLATE AND MENTHOL) LINIMENT [HAW PAR HEALTHCARE LTD.]6Current NDC, Legacy NDC, 2 package rows20241116_51293a06-5922-4072-ae14-afaba9c1b58e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MentholACTIVE INGREDIENTL7T10EIP3A2
Methyl SalicylateACTIVE INGREDIENTLAV5U5022Y2
MentholACTIVE MOIETYL7T10EIP3A2
Salicylic AcidACTIVE MOIETYO414PZ4LPZ2
Eucalyptus oilINACTIVE INGREDIENT2R04ONI6622
light mineral oilINACTIVE INGREDIENTN6K5787QVP2
spike lavender oilINACTIVE INGREDIENT7S2HYV1VJQ2

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
66761-33366761-333-22

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
Eucalyptus oil2R04ONI662IACT
spike lavender oil7S2HYV1VJQIACT
light mineral oilN6K5787QVPIACT

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
light mineral oilLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii+route
16 equally ranked IID candidates
Eucalyptus oilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii+route
16 equally ranked IID candidates
light mineral oilLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii+route
16 equally ranked IID candidates
Eucalyptus oilEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates

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 BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
ndc (package): 66761-333-22
ndc (product): 66761-333
ndc11 (package): 66761033322
spl id: eb6512c3-75f3-40ad-b1ae-fc98677a4e9d
spl set id: 51293a06-5922-4072-ae14-afaba9c1b58e

Reported adverse events (FAERS/openFDA)#

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