NDC 80938-301 Thera-clear

Hydrocolloid

NDC Product Code 80938-301

NDC 80938-301-01

Package Description: 11 g in 1 POUCH

NDC Product Information

Thera-clear with NDC 80938-301 is a a human over the counter drug product labeled by Peach Town Wholesale Inc.. The generic name of Thera-clear is hydrocolloid. The product's dosage form is patch and is administered via topical form.

Labeler Name: Peach Town Wholesale Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Thera-clear 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.

  • CARBOXYMETHYLCELLULOSE 60 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.

  • PECTIN (UNII: 89NA02M4RX)

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: Peach Town Wholesale Inc.
Labeler Code: 80938
Marketing Category: UNAPPROVED DRUG OTHER - 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: 11-06-2020 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.

Thera-clear Product Label Images

Thera-clear 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 Ingredient

Hydrocolloid

Uses

Thin Beveling Type round patch for your skin.Lightly compressed edges make partches seamlessly attached and clear on your skin.

Warning

External use only.Avoid direct sunlight of excessive heat.

Stop Use Ask A Doctor

Stopp using if irratation occurs, and see a doctor if necessary.

Keep Out Of Reach Of Children

Keep out of reach of children

Directions

1. Clean your skin.2. Tear off the release paper along the cut line and attach it to the affected area.3. Make sure the round dressing part wrap around the affected area and gently press 1-2 sec for secure attachment.4. Replace if it swell white due to absorbtion of secretion.

Other Information

Store it room temperature 33.8º-86ºF(1º-30ºC).

Inactive Ingredient

Pectin

Purpose

Acne

Label

80938-301-01

* Please review the disclaimer below.