TIGER BALM NECK AND SHOULDER RUB (camphor- synthetic and menthol 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 Ingredients

Camphor 11%, Menthol 10%

Purpose

Topical analgesics

Uses

For temporary relief of minor aches and pains of neck and shoulder muscles and joints

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 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 breastfeeding, 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, 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

This product may cause allergic reaction in some individuals. Test on small area before use.

Inactive Ingredients

Dementholised Mint Oil, Diazolidinyl Urea, Eucalyptus Oil, FD&C Blue 1, Glycerin, Lavender Fragrance, Methyl Glucose Dioleate, Methylparaben, PVM/MA Decadiene Crosspolymer, Propylene Glycol, Propylparaben, Triethanolamine (TEA), Water.

SPL UNCLASSIFIED SECTION

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

Questions/Comments

(510) 887-1899

PRINCIPAL DISPLAY PANEL - 50g Tube Carton

NDC: 66761-341-50

TIGER BALM®

TIGER BALM®
NECK &
SHOULDER
RUB

Pain Relieving
Cream

Non-Greasy

Soothing
Relief

VANISHING
SCENT

Soothing relief for stressed
and strained muscles

Net Wt. 1.76 oz (50g)

INGREDIENTS AND APPEARANCE

TIGER BALM   NECK AND SHOULDER RUB
camphor (synthetic) and menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-341
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	11 mg  in 1 g
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Eucalyptus oil (UNII: 2R04ONI662)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
Glycerin (UNII: PDC6A3C0OX)
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-341-50	1 in 1 CARTON	10/24/2008
1		50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 66761-341-01	1 in 1 CARTON	10/24/2008
2		5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 66761-341-03	3 g in 1 PACKET; Type 0: Not a Combination Product	10/24/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	10/24/2008

Labeler - Haw Par Healthcare Ltd. (659207039)

Establishment
Name	Address	ID/FEI	Business Operations
OLIC (Thailand) Limited		659673016	MANUFACTURE(66761-341)

Establishment
Name	Address	ID/FEI	Business Operations
Haw Par Healthcare Ltd.		659207039	MANUFACTURE(66761-341)