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

Osteo Bi-Flex Roll-on by

Drug Labeling and Warnings

Osteo Bi-Flex Roll-on by is a Otc medication manufactured, distributed, or labeled by The Nature's Bounty Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Osteo 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24737-1901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	54 g  in 100 g
WATER (UNII: 059QF0KO0R)	29.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24737-1901-3	82 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/31/2019

Labeler - The Nature's Bounty Company (052790318)