TIGER BALM (camphor- synthetic and menthol patch

Tiger Balm by

Drug Labeling and Warnings

Tiger Balm by is a Otc medication manufactured, distributed, or labeled by Haw Par Healthcare Ltd., Teh Seng Pharmaceutical Mfg. Co., Ltd. . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Camphor 230mg / patch	Topical Analgesic
Menthol 70mg / 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 30 minutes after bathing

Stop use and ask a doctor if

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than 7 days

If pregnant or breast-feeding, 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 in some individuals. Store in cool dry place away from direct sunlight.

Inactive Ingredients

Capsicum Extract, Eucalyptus Oil, Glycerin, Mentha Oil, Polyacrylic Acid, Polysorbate 80, Sodium Carboxymethylcellulose, Sodium Polyacrylate, Sorbitan Monooleate, Sorbitol, Tartaric Acid, Water.

Questions/Comments

(510) 887-1899

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 Patch Carton

NDC: 66761-321-04

TIGER BALM®

LARGE

TIGER BALM®
PAIN RELIEVING
LARGE PATCH

Advanced Hydrogel Patch Technology

• Stretchable
• Long Lasting
• Convenient And Not Messy
• It Works!

4 PATCHES (8 x 4 inches each)

INGREDIENTS AND APPEARANCE

TIGER BALM 
camphor (synthetic) and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-321
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	230 mg
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	70 mg

Inactive Ingredients
Ingredient Name	Strength
Eucalyptus Oil (UNII: 2R04ONI662)
Glycerin (UNII: PDC6A3C0OX)
Polysorbate 80 (UNII: 6OZP39ZG8H)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Sorbitol (UNII: 506T60A25R)
Tartaric Acid (UNII: W4888I119H)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-321-04	1 in 1 BOX	01/15/2007
1		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/15/2007

Labeler - Haw Par Healthcare Ltd. (659207039)

Establishment
Name	Address	ID/FEI	Business Operations
Teh Seng Pharmaceutical Mfg. Co., Ltd.		656347721	MANUFACTURE(66761-321)