Osteo Bi-Flex Roll-on

Manufacturer
The Nature's Bounty Company
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:02

Label at a glance#

ProductOsteo Bi-Flex Roll-on Extra Strength
Active ingredientMENTHOL
Label structure13 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: ●arthritis ●simple backache ●strains ●bruises ●sprains

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Purpose: Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles
and joints associated with: ●arthritis ●simple backache ●strains
●bruises ●sprains

WARNINGS SECTION

Warnings: For external use only.

Flammable: Keep away from fire or flame. Store at room temperature.

When using this product

OTC - WHEN USING SECTION

●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

OTC - STOP USE SECTION

●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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health care professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

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

INSTRUCTIONS FOR USE SECTION

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 INGREDIENT SECTION

Inactive ingredients: boswellia serrata extract, carbomer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, glycerin, peppermint oil, SD alcohol 39c, triethanolamine, water.

Questions?

OTC - QUESTIONS SECTION

Call 1-888-VITAHELP (848-2435)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Full LabelFull LabelOsteo BiFlex

Joint Health

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
727161menthol 8 % Topical CreamPSN1
727161menthol 80 MG/ML Topical CreamSCD1
727161menthol 8 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24737-1901-32021-01-29C16284748780-1ba0f9c33-38b5-a910-e053-dadaa90a0b857d653446-f2d4-dd81-e053-2991aa0a088c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24737-1901-3Osteo Bi-Flex Roll-onExtra Strength82 g in 1 BOTTLE, WITH APPLICATORCREAM821

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24737-1901OSTEO BI-FLEX ROLL-ON EXTRA STRENGTH (MENTHOL) CREAM [THE NATURE'S BOUNTY COMPANY]1Legacy NDC, 1 package rows20190331_7d653446-f2d4-dd81-e053-2991aa0a088c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24737-190124737-1901-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7d653446-f2d5-dd81-e053-2991aa0a088c7d653446-f2d4-dd81-e053-2991aa0a088c2018-12-19WarningsExact identifier
spl id: 7d653446-f2d5-dd81-e053-2991aa0a088c
spl set id: 7d653446-f2d4-dd81-e053-2991aa0a088c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.