NDC 65753-400 Coretex Anti-itch Gel

Camphor, Diphenhydramine, Zinc Acetate

NDC Product Code 65753-400

NDC CODE: 65753-400

Proprietary Name: Coretex Anti-itch Gel 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, Diphenhydramine, Zinc Acetate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used after other medications to treat a certain liver disease (Wilson's disease). This inherited disease causes the liver to hold onto too much copper, resulting in liver damage and other serious problems. This medication causes the intestines to make more of a certain substance (a protein) that prevents the body from absorbing too much copper from food, thereby preventing further damage.

NDC Code Structure

NDC 65753-400-02

Package Description: 59 mL in 1 BOTTLE

NDC 65753-400-04

Package Description: 177 mL in 1 BOTTLE

NDC 65753-400-13

Package Description: 25 POUCH in 1 CONTAINER > 1 mL in 1 POUCH

NDC 65753-400-14

Package Description: 300 POUCH in 1 CONTAINER > 1 mL in 1 POUCH

NDC Product Information

Coretex Anti-itch Gel with NDC 65753-400 is a a human over the counter drug product labeled by Coretex Products Inc. The generic name of Coretex Anti-itch Gel is camphor, diphenhydramine, zinc acetate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Coretex Products Inc

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.

Coretex Anti-itch Gel 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) .1 g/100mL
  • ZINC ACETATE 1 g/100mL
  • DIPHENHYDRAMINE HYDROCHLORIDE 2 g/100mL

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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALCOHOL (UNII: 3K9958V90M)
  • WATER (UNII: 059QF0KO0R)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL 1-ALLYL ETHER (UNII: QRB8092KPK)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Coretex Products Inc
Labeler Code: 65753
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: 11-25-2019 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’.

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Coretex Anti-itch Gel Product Label Images

Coretex Anti-itch Gel 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

Camphor 0.1%Diphenhydramine hydrochloride 2%Zinc acetate 1%

Purpose

Extrenal analgesicAntihistamineSkin protectant

Uses

  • For the temporary relief of itching and pain associated with minor skin irritations and rashes due to insect bites, poison ivy, poison oak, poison sumac.dries the oozing and weeping of poison ivy, poison oak, poison sumac.

Warnings

For external use only

Do Not Use

  • On chicken pox, blisters or on extensive areas of the skinwith any drugs containing diphenhydramine while using this product.

When Using This Product

  • Keep out of eyes.

Stop Use And Ask A Doctor If

  • Conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

If swallowed get medical help or contact Poison Control center right away.

Directions

  • Adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily, or as directed bu a doctor.

Other Information

  • Protect this product from excessive heat and direct sun.

Inactive Ingredients

Citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

Questions?

Call: 1-877-684-5774

* Please review the disclaimer below.