Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING CREAM

Manufacturer: Rexall Sundown, LLC
Effective date: 2023-11-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:59:51

Label at a glance#

ProductOsteo Bi-Flex JOINT HEALTH PAIN RELIEVING

Active ingredientMENTHOL, METHYL SALICYLATE

Label structure7 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

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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Methyl Salicylate 10%

Purpose

OTC - PURPOSE SECTION

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

WARNINGS SECTION

For external use only.

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 - ASK DOCTOR 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

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

call 1-888-VITAHELP (848-2435)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1940367	menthol 5 % / methyl salicylate 10 % Topical Cream	PSN	2
1940367	menthol 50 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	2
1940367	menthol 5 % / methyl salicylate 10 % Topical Cream	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59118-837-01	Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	1 in 1 BOX	CREAM	1		2
59118-837-01	Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	71 g in 1 TUBE	CREAM	71		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59118-837	OSTEO BI-FLEX JOINT HEALTH PAIN RELIEVING (MENTHOL, METHYL SALICYLATE) CREAM [REXALL SUNDOWN, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20231111_55c55f1c-d2b3-6363-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING
MENTHOL, METHYL SALICYLATE
INDIAN FRANKINCENSE
CARBOXYPOLYMETHYLENE
ETHYLHEXYLGLYCERIN
GLUCOSAMINE SULFATE
GLYCERYL STEARATE SE
LANOLIN
MAGNESIUM SULFATE, UNSPECIFIED FORM
DIMETHYL SULFONE
PHENOXYETHANOL
POLYSORBATE 80
PROPYLENE GLYCOL
STEARIC ACID
TROLAMINE
WATER
MENTHOL
METHYL SALICYLATE
SALICYLIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59118-837	59118-837-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
INDIAN FRANKINCENSE	4PW41QCO2M	IACT
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
GLUCOSAMINE SULFATE	1FW7WLR731	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
LANOLIN	7EV65EAW6H	IACT
MAGNESIUM SULFATE, UNSPECIFIED FORM	DE08037SAB	IACT
DIMETHYL SULFONE	9H4PO4Z4FT	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	MENTHOL, METHYL SALICYLATE	Rexall Sundown, LLC	55c55f1c-d2b3-6363-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier ndc (package): 59118-837-01 ndc (product): 59118-837 ndc11 (package): 59118083701 spl id: 09d72589-140d-349f-e063-6294a90a4d95 spl set id: 55c55f1c-d2b3-6363-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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