NDC 10742-8169 Mentholatum Pain Relieving

Menthol, Methyl Salicylate

NDC Product Code 10742-8169

NDC 10742-8169-1

Package Description: 1 BOTTLE in 1 CARTON > 100 mL in 1 BOTTLE

NDC 10742-8169-2

Package Description: 1 BOTTLE in 1 CARTON > 75 mL in 1 BOTTLE

NDC Product Information

Mentholatum Pain Relieving with NDC 10742-8169 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Mentholatum Pain Relieving is menthol, methyl salicylate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: The Mentholatum Company

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Pain Relieving 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 60 mg/mL
  • METHYL SALICYLATE 200 mg/mL

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.

  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • LANOLIN OIL (UNII: OVV5IIJ58F)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: 11-01-2018 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: 12-31-2021 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.

Mentholatum Pain Relieving Product Label Images

Mentholatum Pain Relieving 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 6%Methyl salicylate 20%

Purpose

Menthol - Topical analgesicMethyl salicylate - Topical analgesic

Uses

  • Temporarily relieves minor aches and pains of muscles and joints due to •arthritis •simple backache •strains •sprains

When Using This Product

  • •use only as directed •do not get into eyes or on mucous membranes •do not apply to wounds or to damaged skin •do not bandage tightly •do not use with a heating pad, other heat sources, or right after a shower/bath •do not use in combination with other external analgesic products

Stop Use And Ask A Doctor If

  • •condition worsens •excessive irritation, burning or discomfort of the skin develops •symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding,

Ask a healthcare professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • •adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily •children under 12 years: ask a doctor

Inactive Ingredients

Carbomer, lanolin oil, polysorbate 60, purified water, sorbitan monosterate, trolamine

* Please review the disclaimer below.