Active Ingredients
Menthol 8% ..............................................................Topical analgesic
Osteo Bi-flex Roll-on
FDA Label NDC 24737-1901
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Nature's Bounty Company for the product Osteo Bi-flex Roll-on (NDC 24737-1901). 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
Purpose
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
Warnings: For external use only.
Flammable: Keep away from fire or flame. Store at room temperature.
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
●Redness is present
If Pregnant Or Breastfeeding
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:
Directions: adults and children over 12 years: Roll directly onto affected area without the need to rub, massage or bandage. Repeat if necessary, but not more than 4 times daily.
Directions
Directions: adults and children over 12 years: Roll directly onto affected area without the need to rub, massage or bandage. Repeat if necessary, but not more than 4 times daily. ●Children 12 years of age or younger: consult a doctor.
Inactive Ingredients:
Inactive ingredients: boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39c, triethanolamine, water.
Questions?
Call 1-888-VITAHELP (848-2435)
Package Label.Principal Display Panel
Osteo BiFlex
Joint Health
PAIN RELIEVING
ROLL-ON FOR ARTHRITIS, JOINTS & MUSCLES
With DRY TOUCH TECHNOLOGY NON-STICKY, NO RESIDUE, NO MESS
* Please review the disclaimer below.
