TIGER BALM PAIN RELIEVING MUSCLE (methyl salicylate, menthol, unspecified form, and camphor- synthetic spray

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) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients (w/w)	Purpose
Methyl Salicylate 25%	Topical Analgesic
Menthol 16%	Topical Analgesic
Camphor 7%	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
• Avoid inhalation
• Do not use in confined space.

Flammable

• Do not use near heat or flame or while smoking
• Avoid long term storage above 104°F (40°C)
• Do not puncture or incinerate. Contents under pressure
• Do not store at temperatures above 120°F (49°C).

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, spray on the affected area. Repeat 3 to 4 times daily
• For children 12 years of age or younger, consult a doctor before use
• Shake well before use. Point spray towards area to be treated. Spray in short bursts about 6 inches from the skin. The product is quickly absorbed, but may be rubbed in after spraying if desired.

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

Ethanol (Dehydrated Alcohol), Liquefied Petroleum Gas.

Questions

(925) 292-3888

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 75 ml Canister Carton

TIGER BALM®

NDC: 66761-327-75

ACTIVE

Pain Relieving
MUSCLE
SPRAY

• EASY-TO-APPLY
• FOR HARD TO REACH
  AREAS

NET 2.53 Fl. Oz. (75ml)

INGREDIENTS AND APPEARANCE

TIGER BALM   PAIN RELIEVING MUSCLE
methyl salicylate, menthol, unspecified form, and camphor (synthetic) spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (Salicylic Acid - UNII:O414PZ4LPZ)	Methyl Salicylate	250 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	160 mg  in 1 mL
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Liquefied Petroleum Gas (UNII: 5K616HU99V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-327-75	1 in 1 CARTON	05/01/2018
1		75 mL in 1 CANISTER; 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	05/01/2018

Labeler - Haw Par Healthcare Ltd. (659207039)

Establishment
Name	Address	ID/FEI	Business Operations
OLIC (Thailand) Ltd.		659673016	MANUFACTURE(66761-327)