TIGER BALM® Ultra STRENGTH

Tiger Balm by

Drug Labeling and Warnings

Tiger Balm by is a Otc medication manufactured, distributed, or labeled by Tiger Balm (Malaysia) Sdn. Bhd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIGER BALM  ULTRA STRENGTH- camphor (synthetic) and menthol ointment 
Tiger Balm (Malaysia) Sdn. Bhd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TIGER BALM®
Ultra STRENGTH

Drug Facts

Active Ingredients	Purpose
Camphor 11%	Topical Analgesic
Menthol 11%	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 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, 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

Cajuput Oil, Cassia Oil, Clove Oil, Dementholised Mint Oil and Paraffin Petrolatum.

Questions/Comments

(510) 887-1899

PRINCIPAL DISPLAY PANEL - 18 g Carton

NDC: 66403-315-35

TIGER BALM®

Ultra STRENGTH

"WORKS WHERE IT HURTS"

PAIN RELIEVING OINTMENT

SPORTS RUB

TIGER BALM   ULTRA STRENGTH
camphor (synthetic) and menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66403-315
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 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	110 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Cajuput oil (UNII: J3TO6BUQ37)
Chinese Cinnamon Oil (UNII: A4WO0626T5)
Clove oil (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66403-315-35	1 in 1 BOX	01/25/2002	12/31/2019
1		18 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 66403-315-50	1 in 1 BOX	01/25/2002	12/31/2019
2		50 g in 1 JAR; 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	01/25/2002	12/31/2019

Labeler - Tiger Balm (Malaysia) Sdn. Bhd. (652104126)

Establishment
Name	Address	ID/FEI	Business Operations
Tiger Balm (Malaysia) Sdn. Bhd.		652104126	MANUFACTURE(66403-315)

Revised: 12/2018

Document Id: 3302831b-d9a5-4051-978b-0786cebd9b2c

34390-5

Set id: 1dfc4535-3b8d-455c-ae10-4c89773ad63e

Version: 3

Effective Time: 20181220