Osteo Bi-flex Joint Health Pain Relieving Cream
FDA Label NDC 59118-837

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rexall Sundown, Llc for the product Osteo Bi-flex Joint Health Pain Relieving (NDC 59118-837). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, when using this product, discontinue use and consult a doctor if, if pregnant or breastfeeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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