Label: OSTEO BI-FLEX ROLL-ON EXTRA STRENGTH- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated December 19, 2018

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  • Active ingredients

    Menthol 8% ..............................................................Topical analgesic

  • 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)

  • PRINCIPAL DISPLAY PANEL

    Full LabelOsteo BiFlex

    Joint Health

    PAIN RELIEVING
    ROLL-ON FOR ARTHRITIS, JOINTS & MUSCLES
    With DRY TOUCH TECHNOLOGY NON-STICKY, NO RESIDUE, NO MESS

  • INGREDIENTS AND APPEARANCE
    OSTEO BI-FLEX ROLL-ON  EXTRA STRENGTH
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24737-1901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 54 g  in 100 g
    WATER (UNII: 059QF0KO0R) 29.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24737-1901-382 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/31/2019
    Labeler - The Nature's Bounty Company (052790318)
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