NDC 24909-168 Terrasil Infection Protection Wound Care

Calendula, Thuja Occidentalis

NDC Product Code 24909-168

NDC CODE: 24909-168

Proprietary Name: Terrasil Infection Protection Wound Care 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: Calendula, Thuja Occidentalis 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

NDC 24909-168-14

Package Description: 14 g in 1 TUBE

NDC 24909-168-20

Package Description: 200 g in 1 TUBE

NDC 24909-168-50

Package Description: 50 g in 1 TUBE

NDC Product Information

Terrasil Infection Protection Wound Care with NDC 24909-168 is a a human over the counter drug product labeled by Aidance Skincare & Topical Solutions, Llc. The generic name of Terrasil Infection Protection Wound Care is calendula, thuja occidentalis. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Aidance Skincare & Topical Solutions, Llc

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.

Terrasil Infection Protection Wound Care 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.

  • CALENDULA OFFICINALIS FLOWER 1 [hp_X]/50g
  • THUJA OCCIDENTALIS WHOLE 6 [hp_X]/50g

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.

  • WHITE WAX (UNII: 7G1J5DA97F)
  • BENTONITE (UNII: A3N5ZCN45C)
  • COTTONSEED OIL (UNII: H3E878020N)
  • JOJOBA OIL (UNII: 724GKU717M)
  • MAGNESIUM OXIDE (UNII: 3A3U0GI71G)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SAGE OIL (UNII: U27K0H1H2O)
  • SILVER OXIDE (UNII: 897WUN6G6T)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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: Aidance Skincare & Topical Solutions, Llc
Labeler Code: 24909
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: 07-01-2016 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.

Terrasil Infection Protection Wound Care Product Label Images

Terrasil Infection Protection Wound Care 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

Calendula 1X HPUS, Thuja occidentalis 6X HPUSThe letters HPUS indicate the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopeia of the United States

Purpose

Calendula - Healing Agent, Thuja - Skin Eruption Relief

Uses

Helps promote healing of cuts, scrapes and minor burns.

Warnings

For external use only. When using this product, do not get into eyes. Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Consult a doctor before using on deep or puncture wounds, animal bites or serious burns.

Keep Out Of Reach Of Children.

If swallowed, call poison control or seek medical help

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Coverwith a clean bandage. Repeat procedure 1 to 3 times daily until skin improves or as directed by adoctor. Store at room temperature. May stain fabrics.

Inactive Ingredients

Beeswax (organic), bentonite (volcanic clay)**, cotton seed oil, jojoba seed oil, magnesium oxide, peppermint oil, sage oil, silver oxide, tea tree oil, vegetable stearic acid (naturally sourced), zinc oxide. **may contain this ingredient.

* Please review the disclaimer below.