OSTEO BI-FLEX ROLL-ON EXTRA STRENGTH- menthol cream 
The Nature's Bounty Company

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.

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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: 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)

Full LabelOsteo BiFlex

Joint Health

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

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)

Revised: 12/2018
Document Id: 7d653446-f2d5-dd81-e053-2991aa0a088c
Set id: 7d653446-f2d4-dd81-e053-2991aa0a088c
Version: 1
Effective Time: 20181219
 
The Nature's Bounty Company