NDC 72342-010 Menthol Camphor Cough Suppressant Rub

Camphor (natural) And Menthol, Unspecified Form

NDC Product Code 72342-010

NDC Code: 72342-010

Proprietary Name: Menthol Camphor Cough Suppressant Rub What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Camphor (natural) And Menthol, Unspecified Form What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72342 - J.r. Watkins, Llc.
    • 72342-010 - Menthol Camphor Cough Suppressant Rub

NDC 72342-010-16

Package Description: 1 JAR in 1 BOX > 116 g in 1 JAR

NDC Product Information

Menthol Camphor Cough Suppressant Rub with NDC 72342-010 is a a human over the counter drug product labeled by J.r. Watkins, Llc.. The generic name of Menthol Camphor Cough Suppressant Rub is camphor (natural) and menthol, unspecified form. The product's dosage form is ointment and is administered via topical form.

Labeler Name: J.r. Watkins, Llc.

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.

Menthol Camphor Cough Suppressant Rub 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.

  • CAMPHOR (NATURAL) 5.3 g/100g
  • MENTHOL, UNSPECIFIED FORM 2.8 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.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: J.r. Watkins, Llc.
Labeler Code: 72342
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.

Menthol Camphor Cough Suppressant Rub Product Label Images

Menthol Camphor Cough Suppressant Rub 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

Otc - Purpose

Active IngredientsPurposeCAMPHOR 5.3%EXTERNAL ANALGESIC, ANTITUSSIVEMENTHOL 2.8%EXTERNAL ANALGESIC, ANTITUSSIVE

Uses

  • Temporarily relievesminor aches and pains of muscles and jointspain and itching of minor burns, sunburn, minor cuts and scrapescough associated with a cold

Warnings

  • For external use only.Do nottake by mouth or place in nostrilsapply to wounds or damaged skinbandage tightlyget in eyes.

Do Not Use

  • For persistent or chronic cough as occurs with smoking, asthma, or emphysemaif cough is accompanied by excessive phlegm unless directed by a physician.near an open flame by adding to hot waterin a microwave oven. Improper use may cause the mixture to splatter and cause burns.

Otc - Stop Use

  • Discontinue use and consult a physician if cough or other symptomsworsenare accompanied by fever, rash or persistent headachepersist more than 7 daysclear up then recur within a few days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • For adults and children 2 years and older:Foraches, pains or itching; apply to affected area not more than 3-4 times daily.Forcough as occurs with cold; apply thick layer to throat and chest. Area of application may be covered with a warm, dry cloth. Clothing should be left loose about the throat and chest to help the vapors rise to reach nose and mouth. Applications may be repeated up to 3 times or as directed by physician. For children under 2 years of age: Consult a physician.

Other Information

Store away from children at 68-77°F.

Inactive Ingredients

Paraffin, petrolatum

* Please review the disclaimer below.