OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING- menthol, methyl salicylate cream

Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING by

Drug Labeling and Warnings

Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING by is a Otc medication manufactured, distributed, or labeled by Rexall Sundown, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Menthol 5%

Methyl Salicylate 10%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: - arthritis - simple backache - strains - bruises - 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 or damaged, broken or irritated skin
• Do not bandage tightly or apply local heat (such as heating patches) to the area of use

Discontinue use and consult a doctor if

• Condition worsens
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• Irritation develops/excessive irritation occurs

If pregnant or breastfeeding

ask a health care professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. For best results apply daily or as directed by a physician
• After applying, wash hands with soap and water. Children under 12 years of age: consult a doctor.

Inactive ingredients

aloe barbadensis juice, boswellia serrata extract, carbomer, chondroitin sulfate, ethylhexylglycerin, glucosamine sulfate, glyceryl stearate SE, lanolin, magnesium sulfate, methylsulfonylmethane, phenoxyethanol, polysorbate 80, propylene glycol, stearic acid, triethanolamine, water.

Questions?

call 1-888-VITAHELP (848-2435)

Package Labeling:

INGREDIENTS AND APPEARANCE

OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59118-837
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
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LANOLIN (UNII: 7EV65EAW6H)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59118-837-01	1 in 1 BOX	08/01/2017
1		71 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	08/01/2017

Labeler - Rexall Sundown, LLC (080774588)