NDC 77375-004 Clear Itch Relief Evora Labs

Pramoxine Hcl, Zinc Acetate

NDC Product Code 77375-004

NDC CODE: 77375-004

Proprietary Name: Clear Itch Relief Evora Labs 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: Pramoxine Hcl, 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

  • 77375 - Evora Worldwide

NDC 77375-004-02

Package Description: 85 g in 1 BOTTLE, SPRAY

NDC Product Information

Clear Itch Relief Evora Labs with NDC 77375-004 is a a human over the counter drug product labeled by Evora Worldwide. The generic name of Clear Itch Relief Evora Labs is pramoxine hcl, zinc acetate. The product's dosage form is spray and is administered via topical form.

Labeler Name: Evora Worldwide

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Clear Itch Relief Evora Labs 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.

  • PRAMOXINE HYDROCHLORIDE 1 g/100g
  • ZINC ACETATE .1 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.

  • OATMEAL (UNII: 8PI54V663Y)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 40 (UNII: STI11B5A2X)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • WATER (UNII: 059QF0KO0R)

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: Evora Worldwide
Labeler Code: 77375
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: 06-01-2020 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’.

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Clear Itch Relief Evora Labs Product Label Images

Clear Itch Relief Evora Labs 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                               Purpose

Pramoxine HCl                                    Topical analgesicZinc Acetate                                        Skin protectant

Uses

• Temporanly relieves pain and itching associated with:rashes due to poison ivy, poison oak or poison sumac


insect bites


minor skin irritation


minor cuts


dries the oozing and weeping of poison ivy, poison oak and poison sumac

Warnings For External Use Only

Flammable: Do not use while smoking or near heat or flame


Stop use and ask doctor if • condition worsens or does not improve within 7 days • symptoms persist for more than 7 days or clear up and


occur again with 1n a few days


When using this product keep out of eyes. Rinse with water to remove. Do not puncture or incinerate. Contents are under pressure. Do not store at temparatures above 1200F.

Keep Out Or Reach Or Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• shake well before use • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily• children under 2 years of age: ask a doctor

Inactive Inaredients

Avena sativa (OatMeal) Extract, Camphor, Citric Acid, Diazolidinyl Urea, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben,


Polysorbate 40, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Water

Questions?

1-888-793-8450

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