NDC 72197-042 Pharmacys Prescription Vapor Rub

Menthol

NDC Product Code 72197-042

NDC 72197-042-04

Package Description: 110 g in 1 BOTTLE, PLASTIC

NDC Product Information

Pharmacys Prescription Vapor Rub with NDC 72197-042 is a a human over the counter drug product labeled by American Consumer Products Corp. The generic name of Pharmacys Prescription Vapor Rub is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: American Consumer Products Corp

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Pharmacys Prescription Vapor 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.

  • MENTHOL, UNSPECIFIED FORM 1.25 g/100g
  • EUCALYPTUS OIL 1.2 g/100g
  • CAMPHOR (SYNTHETIC) 4.7 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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)
  • 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: American Consumer Products Corp
Labeler Code: 72197
FDA Application Number: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-09-2021 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 ("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".

* Please review the disclaimer below.

Pharmacys Prescription Vapor Rub Product Label Images

Pharmacys Prescription Vapor 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

Active Ingredient

Active IngredientsCamphor 4.7%Menthol 1.25%Eucalyptus Oil 1.2%

Purpose

PurposeDecongestantDecongestantDecongestant

Indications & Usage

USE:To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.

Warning

Warning: For external use only. Not for internal use. Avoid contact with eyes. Do not put in mouth, nostrils, or on wounds or damaged skin.

If Pregnant Or Breast Feeding

If pregnant or breast feeding, consult a physician before use. Do not use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.

Consult A Physician Before Use

Consult a physician before use. If you have asthma, emphysema, persistent or chronic cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days or comes back, or cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.

Keep Out Of Reach Of Children

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

Dosage & Administration

Directions:Adults and children 2 years of age and older, rub a thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds, or rub on sore aching aching muscles. If desired, loosely cover with a soft dry cloth, but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.

Inactive Ingredients

Inactive Ingredients: Petrolatum, Thymol, Turpentine, Cedar Wood Oil, Nutmeg Oil.

* Please review the disclaimer below.