ULTRA BALM- menthol and methyl salicylate ointment

Ultra Balm by

Drug Labeling and Warnings

Ultra Balm by is a Otc medication manufactured, distributed, or labeled by Ling Nam Medicine Factory (H.K.) Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Menthol 14%	Topical analgesic
Methyl Salicylate 23.2%	Topical analgesic

Uses

for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Allergy alert

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

• use only as directed
• avoid contact with eyes or mucous membranes
• do not apply to wounds, damaged or irritated skin
• do not bandage tightly or use with heating pad
• do not use 1 hour prior to bathing or 30 minutes after bathing

Stop use and ask a doctor if

• condition worsens
• skin irritation or redness develops
• pain persists for more than 7 days

If pregnant or breastfeeding, ask health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

• for adults and children 12 years of age and over, apply to affected area not more than 3 to 4 times daily
• for children 12 years or younger, consult a doctor before use
• not intended for children under two years of age

Other information

Close cap tightly after use. Store in cool place.

Inactive ingredients

Eucalyptus Oil, Lanolin, Paraffin, Petroleum Jelly and Thyme Oil

Questions or comments?

Please call 1-718-857-0008. Serious side effects associated with use of this product may be reported to this number.

PRINCIPAL DISPLAY PANEL - 19.8 g Jar Carton

NDC.No : 57598-888-07

ULTRA BALM

LING NAM®
EXTERNAL ANALGESIC

COOLING
PAIN
RELIEF

Ling Nam Medicine Factory (H.K.) Limited
Tuen Mun, New Territories, Hong Kong

Product of Hong Kong
Net Wt.0.7 oz (19.8g)

INGREDIENTS AND APPEARANCE

ULTRA BALM 
menthol and methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57598-888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	140 mg  in 1 g
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	232 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Eucalyptus Oil (UNII: 2R04ONI662)
Lanolin (UNII: 7EV65EAW6H)
Paraffin (UNII: I9O0E3H2ZE)
Petrolatum (UNII: 4T6H12BN9U)
Thyme Oil (UNII: 2UK410MY6B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57598-888-25	1 in 1 CARTON	08/01/2013	09/19/2017
1		70.8 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 57598-888-07	1 in 1 CARTON	08/01/2013
2		19.8 g in 1 JAR; Type 0: Not a Combination Product
3	NDC: 57598-888-23	1 in 1 CARTON	09/19/2017
3		65.1 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	08/01/2013

Labeler - Ling Nam Medicine Factory (H.K.) Ltd. (667152748)

Establishment
Name	Address	ID/FEI	Business Operations
Ling Nam Medicine Factory (H.K.) Ltd.		667152748	MANUFACTURE(57598-888)