JOINT AND MUSCLE PAIN- menthol cream

Joint and Muscle Pain by

Drug Labeling and Warnings

Joint and Muscle Pain by is a Otc medication manufactured, distributed, or labeled by BioZone Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol (5%)

PURPOSE

Topical Analgesic

Directions

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

• Backache
• Arthritis
• Bruises
• Sprains

Warnings

• For external use only. Do not use with a heating pad.  Do not apply to wounds or damaged skin. Do not bandage tightly after use.
• Avoid contact with eyes.
• Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
• Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Directions

• Adults and children over the age of 2: Apply generously to affected area.  Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily.
• Children under the age of 2: Do not use; consult a physician.

Inactive Ingredients

Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.

PRINCIPAL DISPLAY PANEL

Image: tube_shk10_1.jpg

INGREDIENTS AND APPEARANCE

JOINT AND MUSCLE PAIN 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55379-404
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	50 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55379-404-85	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/15/2009

Labeler - BioZone Laboratories, Inc. (555564293)