TIGER BALM PAIN RELIEVING COOL (camphor- synthetic and menthol, unspecified form patch

Tiger Balm by

Drug Labeling and Warnings

Tiger Balm by is a Otc medication manufactured, distributed, or labeled by Haw Par Healthcare Ltd., Tiger Balm (Malaysia) Sdn. Bhd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Camphor 80mg / patch	Topical Analgesic
Menthol 24mg / patch	Topical Analgesic

Uses

For temporary relief of pains.

Warnings

FOR EXTERNAL USE ONLY

When using this product

• 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

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than 7 days, or redness is present
• Symptoms clear up and occur again within a few days

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

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

Directions

• 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

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

Inactive Ingredients

Carboxymethylcellulose Sodium, Castor Oil, Dihydroxyaluminum Aminoacetate, Disodium Edetate, Eucalyptus Oil, Glycerin, Heavy Kaolin, Mentha Oil, Polyacrylic Acid, Purified Water. Polysorbate 80, Polyvinyl Alcohol, Sorbitol Solution, Sodium Polyacrylate, Tartaric Acid, Urea.

Questions/Comments

(925) 292-3888

PRINCIPAL DISPLAY PANEL - 5 Patch Packet

NDC: 66761-325-05

TIGER BALM®

TIGER BALM®
PAIN RELIEVING
COOL PATCH

Advanced Hydrogel Patch Technology
Fast Acting Cooling Effect

For temporary relief of pains

• Works Where it Hurts
• Long Lasting
• Easy to Apply and Remove
• Convenient

5 PATCHES (4 x 2.75 inches each)

INGREDIENTS AND APPEARANCE

TIGER BALM   PAIN RELIEVING COOL
camphor (synthetic) and menthol, unspecified form patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	80 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	24 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CASTOR OIL (UNII: D5340Y2I9G)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SORBITOL SOLUTION (UNII: 8KW3E207O2)
TARTARIC ACID (UNII: W4888I119H)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-325-05	1 in 1 BOX	04/01/2025
1		5 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	04/01/2025

Labeler - Haw Par Healthcare Ltd. (659207039)

Establishment
Name	Address	ID/FEI	Business Operations
Haw Par Healthcare Ltd.		659207039	MANUFACTURE(66761-325)

Establishment
Name	Address	ID/FEI	Business Operations
Tiger Balm (Malaysia) Sdn. Bhd.		813058014	MANUFACTURE(66761-325)