NDC 80591-001 Elizabeth Health Style Chestrub Vaporizing Action

Camphor (synthetic), Levomenthol, Eucalyptus

NDC Product Code 80591-001

NDC CODE: 80591-001

Proprietary Name: Elizabeth Health Style Chestrub Vaporizing Action 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 (synthetic), Levomenthol, Eucalyptus 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

  • 80591 - Ayushree Pharmaceuticals Private Limited
    • 80591-001 - Elizabeth Health Style Chestrub Vaporizing Action

NDC 80591-001-01

Package Description: 113 g in 1 DRUM

NDC Product Information

Elizabeth Health Style Chestrub Vaporizing Action with NDC 80591-001 is a a human over the counter drug product labeled by Ayushree Pharmaceuticals Private Limited. The generic name of Elizabeth Health Style Chestrub Vaporizing Action is camphor (synthetic), levomenthol, eucalyptus. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Ayushree Pharmaceuticals Private Limited

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.

Elizabeth Health Style Chestrub Vaporizing Action 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 (SYNTHETIC) 5 g/100g
  • LEVOMENTHOL 2.6 g/100g
  • EUCALYPTUS OIL 1.2 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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • WHITE PINE OIL (UNII: HA5CX6676U)
  • 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.
  • 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: Ayushree Pharmaceuticals Private Limited
Labeler Code: 80591
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: 09-28-2020 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.

Elizabeth Health Style Chestrub Vaporizing Action Product Label Images

Elizabeth Health Style Chestrub Vaporizing Action 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

Use

  • Temporarily relieves symptoms associated with the common cold:coughnasal congestionchest congestionTemporarily relieves minor aches and pains of muscles.

Warnings

  • For external use only. Avoid contact with eyes.Ask a doctor before use if you haveCough with excessive phlegm (mucus)Chronic cough that lasts or as occurs with smoking, asthma or emphysema.When using this product do notheatmicrowaveadd to hot water or any container where heating water.May cause splattering and result in burns.Muscle aches and pains persist for more than 7 days or come back.Cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be sign of a serious conditionIf pregnant or breast-feeding, consult a physician before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • See important warnings under "Do not use this product".Children under 2 years of age, ask a doctor.Adults and children 2 years of age or older: Rub a thick layer on chest and throat. If desired. loosely cover with a soft dry cloth but keep clothing loose.Repeat up to 3 times daily, or as directed by a doctor.

Inactive Ingredients

BHT, Cedar Oil, Hard Wax, Light Liquid Paraffin, Micro Wax, Nutmeg Oil, Pine Oil, Thymol.

* Please review the disclaimer below.