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

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Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING CREAM

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

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:

Label

OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59118-837
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59118-837-011 in 1 BOX08/01/2017
171 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/01/2017
Labeler - Rexall Sundown, LLC (080774588)

Revised: 11/2023
Document Id: 09d72589-140d-349f-e063-6294a90a4d95
Set id: 55c55f1c-d2b3-6363-e054-00144ff88e88
Version: 2
Effective Time: 20231110
 
Rexall Sundown, LLC