NDC 80591-002 Elizabeth Health Style Ice Cold

Camphor (synthetic), Levomenthol

NDC Product Code 80591-002

NDC CODE: 80591-002

Proprietary Name: Elizabeth Health Style Ice Cold 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 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

NDC 80591-002-01

Package Description: 227 g in 1 DRUM

NDC Product Information

Elizabeth Health Style Ice Cold with NDC 80591-002 is a a human over the counter drug product labeled by Ayushree Pharmaceuticals Private Limited. The generic name of Elizabeth Health Style Ice Cold is camphor (synthetic), levomenthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ayushree 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.

Elizabeth Health Style Ice Cold 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) 2.5 g/100g
  • LEVOMENTHOL .5 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.

  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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 Ice Cold Product Label Images

Elizabeth Health Style Ice Cold 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

For the temporary relief of minor aches and pains in muscle and joints associated with:• simple backache • strains • sprains• sports injuries • arthritis • bruises

Warnings

  • For external use onlyDo not use • with other topical pain relievers •with heating pads or heating devices.When using this productdo not use in or near eyesdo not apply to wounds or damaged skindo not bandage tightlyWhen using this productdo not use in or near eyesdo not apply to wounds or damaged skindo not bandage tightlyStop use and ask doctor ifConditions worsens symptoms last more than 7 days or clear up and occur again within a few daysredness or irritation developIf pregnant or breast-feeding, ask a heath professional 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 right away.

Directions

  • Clean affected area before applying product       adults and children 2 year of age and older: apply to affected areanot more than 3 to 4 times daily.

Inactive Ingredients

Carbomer 940, Color: FD&C Blue No.1, lsopropyl Alcohol, Methyl Chloroisothiazolinone, Methyl lsothiazolinone, Propylene Glycol, Purified Water, Triethanolamine.Questions? ca11 305-627-3116

* Please review the disclaimer below.