NDC 41167-0410 Gold Bond Medicated Extra Strength Body

Menthol

NDC Product Code 41167-0410

NDC 41167-0410-4

Package Description: 283 g in 1 BOTTLE

NDC 41167-0410-5

Package Description: 113 g in 1 BOTTLE

NDC Product Information

Gold Bond Medicated Extra Strength Body with NDC 41167-0410 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Gold Bond Medicated Extra Strength Body is menthol. The product's dosage form is powder and is administered via topical form.

Labeler Name: Chattem, Inc.

Dosage Form: Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

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.

Gold Bond Medicated Extra Strength Body 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.

  • STARCH, CORN (UNII: O8232NY3SJ)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • ACACIA (UNII: 5C5403N26O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
  • EUCALYPTOL (UNII: RV6J6604TK)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • THYMOL (UNII: 3J50XA376E)

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: Chattem, Inc.
Labeler Code: 41167
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: 03-01-2021 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: 12-31-2022 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 - NO 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.

Gold Bond Medicated Extra Strength Body 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

Purpose

Menthol 0.8%..................................................................................................................................................
     
Anti-itch

Uses

Temporarily relieves the pain and itch associated with:■ minor cuts  ■ sunburn  ■ insect bites  ■ scrapes ■ minor burns ■ minor skin irritations

Warnings

For external use only

When Using This Product

■ avoid contact with eyes

Stop Use And Ask A Doctor If

■ condition worsens■ symptoms persist for more than 7 days or clear up and occur again within a few days■ redness, irritation, swelling or pain persists or increases

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ adults and children 2 years and older: apply freely up to 3 or 4 times daily  ■ children under 2 years: ask a doctor■ for best results dry skin thoroughly before applying

Inactive Ingredients

Zea mays (corn) starch, zinc oxide, acacia senegal gum, silica, tricalcium phosphate, eucalyptol, methyl salicylate, salicylic acid, zinc stearate, thymol

* Please review the disclaimer below.