NDC 47046-991 Chest Rub And Cough Suppressant

Menthol And Camphor And Eucalyptus Oil

NDC Product Code 47046-991

NDC CODE: 47046-991

Proprietary Name: Chest Rub And Cough Suppressant 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: Menthol And Camphor And Eucalyptus Oil 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

  • 47046 - Anicare Pharmaceuticals Private Limited

NDC 47046-991-14

Package Description: 113 g in 1 JAR

NDC Product Information

Chest Rub And Cough Suppressant with NDC 47046-991 is a a human over the counter drug product labeled by Anicare Pharmaceuticals Private Limited. The generic name of Chest Rub And Cough Suppressant is menthol and camphor and eucalyptus oil. The product's dosage form is gel and is administered via topical form.

Labeler Name: Anicare Pharmaceuticals Private Limited

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.

Chest Rub And Cough Suppressant 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) 5.31 g/113g
  • MENTHOL 2.26 g/113g
  • EUCALYPTUS OIL 1.13 g/113g

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)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • TURPENTINE (UNII: XJ6RUH0O4G)
  • THYMOL (UNII: 3J50XA376E)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)

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: Anicare Pharmaceuticals Private Limited
Labeler Code: 47046
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: 01-29-2021 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 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.

Chest Rub And Cough Suppressant Product Label Images

Chest Rub And Cough Suppressant 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 2.0%Camphor 4.7%Eucalyptus Oil 1.0%

Purpose

Decongestant

Use:

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

Warnings:

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding: Consult a physician before use.

Otc - Do Not Use

Do notuse 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.

Otc - 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.

Otc - Ask Doctor

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

Directions:

Adults and children 2 years of age and older rub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, 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:

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil

* Please review the disclaimer below.