NDC 24737-1901 Osteo Bi-flex Roll-on Extra Strength

Menthol

NDC Product Code 24737-1901

NDC 24737-1901-3

Package Description: 82 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Osteo Bi-flex Roll-on Extra Strength with NDC 24737-1901 is a a human over the counter drug product labeled by The Nature's Bounty Company. The generic name of Osteo Bi-flex Roll-on Extra Strength is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Nature's Bounty Company

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Osteo Bi-flex Roll-on Extra Strength Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL 8 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: The Nature's Bounty Company
Labeler Code: 24737
FDA Application Number: part341 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-31-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Osteo Bi-flex Roll-on Extra Strength Product Label Images

Osteo Bi-flex Roll-on Extra Strength Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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)

* Please review the disclaimer below.

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