TIGER BALM PAIN RELIEVING HYDROGEL (camphor- synthetic, levomenthol, and capsicum patch

TIGER Balm by

Drug Labeling and Warnings

TIGER Balm by is a Otc medication manufactured, distributed, or labeled by Haw Par Healthcare Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Camphor 160mg / patch	Topical Analgesic
Menthol 48mg / patch	Topical Analgesic
Capsicum Extract 32mg / 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
• Symptoms clears 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 a Poison Control Center right away.

Directions

• Adults and children 12 years and over apply to the 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

Other Information

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

Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, hydrotalcite, kaolin, mentha oil, polysorbate 80, polyacrylic acid solution, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, sorbitol solution, water

Questions/Comments

(925) 292-3888

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 2 Patch Pouch

2 PATCH PACK
X WIDER SIZE*

*As compared to our
Regular Size Patch (4" x 2.75")

NDC: 66761-354-02

TIGER BALM®

TIGER BALM®
PAIN RELIEVING
PATCH

Advanced Hydrogel Patch Technology

For temporary relief of pains

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

2 PATCHES (3.9 x 5.5 inches each)

LOT:

EXP:

INGREDIENTS AND APPEARANCE

TIGER BALM   PAIN RELIEVING HYDROGEL
camphor (synthetic), levomenthol, and capsicum patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	160 mg
Levomenthol (UNII: BZ1R15MTK7) (Levomenthol - UNII:BZ1R15MTK7)	Levomenthol	48 mg
Capsicum (UNII: 00UK7646FG) (Capsicum - UNII:00UK7646FG)	Capsicum	32 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
Eucalyptus Oil (UNII: 2R04ONI662)
Glycerin (UNII: PDC6A3C0OX)
Kaolin (UNII: 24H4NWX5CO)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Propylene Glycol (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-354-02	2 in 1 POUCH; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	03/01/2021

Labeler - Haw Par Healthcare Ltd. (659207039)

Establishment
Name	Address	ID/FEI	Business Operations
Haw Par Healthcare Ltd.		659207039	MANUFACTURE(66761-354)

Establishment
Name	Address	ID/FEI	Business Operations
Tiger Balm (Malaysia) Sdn. Bhd.		813058014	MANUFACTURE(66761-354)