ULTRA STRENGTH PAIN RELIEF BALM- camphor, menthol gel

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 McCure Health Solutions Inc., Jiangsu Dedi Medical Device Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Camphor 11%

Menthol 11%

Purpose

Topical analgesic

Uses

For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.

Warnings

For external use only

When using this product

• Avoid contact with eyes and mocous membranes
• Do not apply to open wounds or damaged skin
• Do not bandage or use heating pad

Stop use and ask a doctor if

• Condition worsens
• Severe skin irritation occurs.
• Pain persists for more than seven days
• Pain clears up and then recurs a few days later

If pregnant or breast-feeding,

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

• Rub well on the affected area. Repeat 3 to 4 times daily

Other information

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

Inactive ingredients

CAJUPUT OIL, CLOVE OIL, DEMENTHOLIZED MINT OIL, PARAFFIN PETROLATUMA

Product Label

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH PAIN RELIEF BALM 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	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)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52486-013-18	1 in 1 CARTON	03/27/2015
1		18 g in 1 TUBE; 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	03/27/2015

Labeler - McCure Health Solutions Inc. (053034873)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Dedi Medical Device Co., Ltd.		544458936	manufacture(52486-013)