TIGER BALM ARTHRITIS RUB (camphor- synthetic and menthol, unspecified form 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
Camphor 11%	Topical Analgesic
Menthol 11%	Topical Analgesic

Uses

For the temporary relief of minor aches and pains associated with arthritis, backache, stiffness, muscle 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

• Shake well before using
• Apply generously to affected areas and massage gently until cream is absorbed into the skin
• For adults and children over 12, rub well on the affected area. Repeat 3-4 times daily
• For children 12 years of age or younger, consult a doctor before use.

Other Information

• This product may cause allergic reaction on some individuals. Test on small area before use
• As part of its warming action, temporary redness may occur.

Inactive Ingredients

Cajuput Oil, Chondroitin Sulfate, Cinnamon Oil, Clove Oil, Purified Water, Dementholised Mint Oil, Diazolidinyl Urea, Glucosamine Sulfate, Methyl Paraben, Methylsulfonylmethane (MSM), PEG-120 Methyl Glucose Dioleate, Propyl Paraben, Propylene Glycol.

Questions/Comments

(925) 292 3888

PRINCIPAL DISPLAY PANEL - 113 mL Bottle Carton

NDC: 66761-422-04

TIGER BALM®

Easy to use pump

TIGER BALM®
ARTHRITIS RUB

Effective
Arthritis Pain
Relieving Cream

Containing:
Camphor, Menthol

Alcohol-Free. Moisturizing Formula.

NET 4 Fl Oz (113mL)

INGREDIENTS AND APPEARANCE

TIGER BALM   ARTHRITIS RUB
camphor (synthetic) and menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66761-422
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET)	Camphor (Synthetic)	110 mg  in 1 mL
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	110 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Cajuput Oil (UNII: J3TO6BUQ37)
Cinnamon Oil (UNII: E5GY4I6YCZ)
Clove Oil (UNII: 578389D6D0)
Water (UNII: 059QF0KO0R)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)
Glucosamine Sulfate (UNII: 1FW7WLR731)
Methylparaben (UNII: A2I8C7HI9T)
Dimethyl Sulfone (UNII: 9H4PO4Z4FT)
PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Propylparaben (UNII: Z8IX2SC1OH)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66761-422-04	1 in 1 CARTON	12/01/2022
1		113 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M017	12/01/2022

Labeler - Haw Par Healthcare Ltd. (659207039)

Establishment
Name	Address	ID/FEI	Business Operations
OLIC (Thailand) Limited		659673016	MANUFACTURE(66761-422)