Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING: Package Insert and Label Information

OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING- menthol and methyl salicylate cream
Rexall Sundown, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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:

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 50 mg in 1 g METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 100 mg in 1 g

Inactive Ingredients Ingredient Name Strength INDIAN FRANKINCENSE CARBOXYPOLYMETHYLENE ETHYLHEXYLGLYCERIN GLUCOSAMINE SULFATE GLYCERYL STEARATE SE LANOLIN MAGNESIUM SULFATE, UNSPECIFIED FORM DIMETHYL SULFONE PHENOXYETHANOL POLYSORBATE 80 PROPYLENE GLYCOL STEARIC ACID TROLAMINE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:59118-837-01 1 TUBE in 1 BOX contains a TUBE 1 71 g in 1 TUBE This package is contained within the BOX (59118-837-01)

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)

Revised: 08/2017 Rexall Sundown, LLC