NDC 68428-721 Be Gone Scars TM

Thiosinaminum

NDC Product Code 68428-721

NDC 68428-721-29

Package Description: 56 g in 1 TUBE

NDC Product Information

Be Gone Scars TM with NDC 68428-721 is a a human over the counter drug product labeled by Washington Homeopathic Products. The generic name of Be Gone Scars TM is thiosinaminum. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Washington Homeopathic Products

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.

Be Gone Scars TM 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.

  • ALLYLTHIOUREA 2 [hp_X]/56g

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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • LANOLIN (UNII: 7EV65EAW6H)

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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Washington Homeopathic Products
Labeler Code: 68428
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 03-15-2013 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.

Be Gone Scars TM Product Label Images

Be Gone Scars TM 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

THIOSINAMINUM   2X

Uses

To diminish scars.

Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children.

Indications

Indications:THIOSINAMINUM   Scarring

Stop Use And Ask Doctor

For external use only. If symptoms persist/worsen or if pregnant/nursing, consult your practitioner. Do not use if inner foil seal is broken or missing.

Directions

Apply to scar and rub in.

Inactive Ingredients

50% Lanolin50% Petrolatum

* Please review the disclaimer below.