TIGER BALM MUSCLE RUB PAIN RELIEVING (methyl salicylate, menthol, and camphor- synthetic cream

Tiger Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Methyl Salicylate 15%	Topical Analgesic
Menthol 5%	Topical Analgesic
Camphor 3%	Topical Analgesic

Uses

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

Warnings

For external use only

When using this product

• 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

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than 7 days
• Pain clears up and then recurs a few days later.

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 immediately.

Directions

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

Other Information

• Allergy alert: 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
• Store at room temperature.

Inactive Ingredients

Diazolidinyl Urea, Glycerin, Methyl Glucose Dioleate, Methyl Paraben, Poly (Methyl Vinyl Ether / Maleic Anhydride) Decadiene Crosspolymer, Propyl Paraben, Propylene Glycol, Purified Water, Triethanolamine.

SPL UNCLASSIFIED SECTION

Manufactured by OLIC (Thailand) Limited for Haw Par
Healthcare Ltd., Singapore under licence from Haw Par
Corporation Ltd.

PRINCIPAL DISPLAY PANEL - 57 G Tube Box

NDC: 66761-122-60

TIGER BALM®

MUSCLE RUB

Pain Relieving Cream

Temporary relief of minor aches and pains
Effective for pre-exercise warm-up

Non-Greasy Easy to Apply

NET WT. 2 OZ. (57G)

INGREDIENTS AND APPEARANCE

TIGER BALM  MUSCLE RUB PAIN RELIEVING
methyl salicylate, menthol, and camphor (synthetic) cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	50 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-122-60	1 in 1 BOX	05/01/2013	11/30/2020
1		57 g in 1 TUBE; 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	05/01/2013	11/30/2020

Labeler - Haw Par Healthcare Ltd. (659207039)

Registrant - OLIC (Thailand) Limited (659673016)