ULTRA STRENGTH PAIN RELIEF BALM- camphor menthol ointment 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 MCURE HEALTH SOLUTIONS, Suzhou Vastech Medical Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Camphor 11%........................................................ Topical analgesic

Menthol 11%.......................................................... Topical analgesic

PURPOSE

Uses

For temporary relief of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and spraings

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

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

STOP USE

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

ASK DOCTOR

If pregnant or breast feeding, 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

INDICATIONS & USAGE

Directions

• Rub well on the affected area. Repeat 3 to 4 times dailys.
• For children 2-12 years, consult a doctor before use

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

Inactive ingredients
cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma

DOSAGE & ADMINISTRATION

Distributed by:
MCURE HEALTH SOLUTIONS INC.
20819 Currier Rd #200
City of Industry, CA 91789
Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA STRENGTH PAIN RELIEF BALM 
camphor menthol ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52486-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	11 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAJUPUT OIL (UNII: J3TO6BUQ37)
CLOVE OIL (UNII: 578389D6D0)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52486-320-18	18 g in 1 BOTTLE; Type 0: Not a Combination Product	03/20/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/20/2017

Labeler - MCURE HEALTH SOLUTIONS (053034873)

Establishment
Name	Address	ID/FEI	Business Operations
Suzhou Vastech Medical Technology Co., Ltd		543772485	manufacture(52486-320)