ULTRA STRENGTH PAIN RELIEF BALM- camphor, menthol ointment

Ultra Strength Pain Relief Balm by

Drug Labeling and Warnings

Ultra Strength Pain Relief Balm by is a Otc medication manufactured, distributed, or labeled by ALAINA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Camphor 11%

Menthol 11%

Purpose

Camphor-Topical Analgesic
Menthol-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

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 on some individuals. Test on a small area before use.

Inactive Ingredients

cajuput oil, cassia oil, clove oil, dementholized mint oil, paraffin base.

Questions or comments? Call

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Haw Par Healthcare Ltd., owner of the registered trademark of Tiger Balm Ultra Strength [pain relieving ointment].

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ultra Strength Pain Relief Balm

For temporary relief of minor aches & pains due to:

• Backache
• Arthritis
• Bruises
• Sprains
• Joint Pains
  Pain Relieving Ointment
• Ultra Strength
• Concentrated

Net wt 0.63 oz (18g)

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH PAIN RELIEF BALM 
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73492-711
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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	110 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
CHINESE CINNAMON OIL (UNII: A4WO0626T5)
CLOVE OIL (UNII: 578389D6D0)
PEPPERMINT OIL (UNII: AV092KU4JH)
PARAFFIN (UNII: I9O0E3H2ZE)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73492-711-18	1 in 1 CARTON	01/27/2022
1		18 g in 1 BOTTLE, GLASS; 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	01/27/2022

Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)

Establishment
Name	Address	ID/FEI	Business Operations
ALAINA HEALTHCARE PRIVATE LIMITED		858720927	manufacture(73492-711)