NDC 69968-0596 Bengay Ultra Strength Regular Size

Menthol, Unspecified Form

NDC Product Code 69968-0596

NDC 69968-0596-5

Package Description: 5 POUCH in 1 CARTON > 1 PATCH in 1 POUCH

NDC Product Information

Bengay Ultra Strength Regular Size with NDC 69968-0596 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Bengay Ultra Strength Regular Size is menthol, unspecified form. The product's dosage form is patch and is administered via topical form.

Labeler Name: Johnson & Johnson Consumer Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Bengay Ultra Strength Regular Size 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, UNSPECIFIED FORM 50 mg/1

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.

  • KAOLIN (UNII: 24H4NWX5CO)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • SORBITOL (UNII: 506T60A25R)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
FDA Application Number: part348 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 09-01-2019 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.

Bengay Ultra Strength Regular Size Product Label Images

Bengay Ultra Strength Regular Size 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

Other

Drug Facts

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints associated with:simple backachearthritisstrainsbruisessprains

Warnings

For external use only.

Do Not Use

  • On wounds or damaged skinwith a heating padon a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor

Ask a doctor before use if you have redness over the affected area

When Using This Product

  • Avoid contact with eyes or mucous membranesdo not bandage tightly

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Open pouch and remove patchif desired, cut patch to sizepeel off protective backing and apply sticky side to affected areaadults and children 12 years of age and older: apply to affected area not more than 3 to 4 times dailychildren under 12 years of age: ask a doctor

Other Information

  • Store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

Calcined kaolin, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, polyacrylic acid, polysorbate 80, propylparaben, silica, sodium polyacrylate, sodium polyacrylate starch, sorbitan oleate, sorbitol, tartaric acid, titanium dioxide, water

Questions?

Call 1-800-223-0182 (toll-free) or 215-273-8755 (collect)

* Please review the disclaimer below.