NDC 10742-0002 Mentholatum Original

Camphor, Menthol

NDC Product Code 10742-0002

NDC 10742-0002-1

Package Description: 1 JAR in 1 CARTON > 28 g in 1 JAR

NDC 10742-0002-2

Package Description: 1 JAR in 1 CARTON > 85 g in 1 JAR

NDC 10742-0002-3

Package Description: 1 JAR in 1 CARTON > 34 g in 1 JAR

NDC 10742-0002-4

Package Description: 1 JAR in 1 CARTON > 102.1 g in 1 JAR

NDC Product Information

Mentholatum Original with NDC 10742-0002 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Mentholatum Original is camphor, menthol. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1042663 and 1042667.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Mentholatum Original 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.


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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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 Mentholatum Company
Labeler Code: 10742
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: 12-01-2014 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Mentholatum Original Product Label Images

Mentholatum Original 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

Camphor 9%Menthol 1.3%

Purpose

Camphor - Topical AnalgesicMenthol - Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only

When Using This Product

  • •do not get into eyes •do not apply to wounds or to damaged skin •do not bandage tightly •do not heat, microwave, or add to hot water as this may cause splattering and result in burns

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

Keep Out Of Reach Of Children.

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

Directions

  • •adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily •children under 2 years: ask a doctor

Inactive Ingredients

Fragrance, petrolatum, titanium dioxide

Questions?

Toll free 1-877-636-2677 MON-FRI 9AM to 5PM (EST)

* Please review the disclaimer below.