FDA.reportPublic FDA data

TIGER BALM

Manufacturer
Haw Par Healthcare Ltd. | Teh Seng Pharmaceutical Mfg. Co., Ltd.
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:07:37

Label at a glance#

ProductTIGER BALM PAIN RELIEVING HYDROGEL
Active ingredientCamphor (Synthetic), Levomenthol, Capsicum
Label structure9 sections

Indications and uses

For temporary relief of pains.

Dosage and administration

Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily Children under 12 years, consult doctor before use How to apply: Clean and dry affected area Cut open pouch and remove patch Remove protective film and apply directly to area of pain Apply to affected area not more than 3 times daily Wash hands with soap after applying patch Reseal pouch containing unused patches

Storage and handling

This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
DL-Camphor 110mg/patchTopical Analgesic
L-Menthol 33mg/patchTopical Analgesic
Capsicum Extract 22mg/patchTopical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pains.

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • 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
  • Symptoms clear up and occur again within a few days

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 Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

Other Information

STORAGE AND HANDLING SECTION

This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Eucalyptus Oil, Glycerin, Mentha Oil, Methyl Acrylate and 2-Ethylhexyl Acrylate Copolymer, Purified Water, Polysorbate 80, PVA Solution, Silicon Dioxide, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Monooleate, Sorbitol Solution, Tartaric Acid

Questions/Comments

OTC - QUESTIONS SECTION

(925) 292-3888

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Larger Size
Limited Time Offer

NDC 66761-323-05

TIGER BALM®

TIGER BALM®
PAIN RELIEVING
HYDROGEL PATCH

Advanced Hydrogel Patch Technology

For temporary relief of pains

  • Convenient And Not Messy
  • Works Where It Hurts
  • Long Lasting

5 PATCHES (4.75 x 3.14 inches each)

PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1994328Capsicum extract 22 MG / levomenthol 33 MG / synthetic camphor 110 MG Medicated PatchPSN6
1994328Capsicum extract 22 MG / levomenthol 33 MG / synthetic camphor 110 MG Medicated PatchSCD6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAPSICUM Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66761-323-05TIGER BALM PAIN RELIEVING HYDROGEL5 in 1 POUCHPATCH56
66761-323-05TIGER BALM PAIN RELIEVING HYDROGEL1 in 1 BOXPATCH16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66761-323-05EA - Each66761-323b6ebb526-b132-4324-a134-206672baff3d12025-11-13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66761-32366761-323-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Camphor (Synthetic)5TJD82A1ETACTIB
LevomentholBZ1R15MTK7ACTIB
Capsicum00UK7646FGACTIB
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
Eucalyptus Oil2R04ONI662IACT
GlycerinPDC6A3C0OXIACT
Water059QF0KO0RIACT
Polysorbate 806OZP39ZG8HIACT
Silicon DioxideETJ7Z6XBU4IACT
Sorbitan Monooleate06XEA2VD56IACT
Sorbitol506T60A25RIACT
Tartaric AcidW4888I119HIACT

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 HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
ndc (package): 66761-323-05
ndc (product): 66761-323
ndc11 (package): 66761032305
spl id: fa36ee93-8866-44ab-a1ef-aebb23a4e798
spl set id: cb60037f-bceb-4090-a5e4-bdda0cbf9f5c

Reported adverse events (FAERS/openFDA)#

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