NDC 24909-731 Cbdmedic Itch And Rash

Allantoin, Lidocaine Hcl

NDC Product Code 24909-731

NDC 24909-731-40

Package Description: 1 TUBE in 1 CARTON > 40 g in 1 TUBE

NDC Product Information

Cbdmedic Itch And Rash with NDC 24909-731 is a a human over the counter drug product labeled by Aidance Skincare & Topical Solutions, Llc. The generic name of Cbdmedic Itch And Rash is allantoin, lidocaine hcl. 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.

Cbdmedic Itch And Rash 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.

  • ALLANTOIN 5 mg/g
  • LIDOCAINE 5 mg/g

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)
  • COTTONSEED OIL (UNII: H3E878020N)
  • HEMP (UNII: TD1MUT01Q7)
  • JOJOBA OIL (UNII: 724GKU717M)
  • PALMAROSA OIL (UNII: 0J3G3O53ST)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SILVER OXIDE (UNII: 897WUN6G6T)
  • SORBIC ACID (UNII: X045WJ989B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • 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
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: 03-06-2019 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’.

* Please review the disclaimer below.

Cbdmedic Itch And Rash Product Label Images

Cbdmedic Itch And Rash 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 And Purpose

Allantoin 0.5% (Skin Protectant),Lidocaine HCl 0.5% (External Analgesic)

Uses

For temporary relief and protection from itching associated with minor skin irritations and rashes.

Warnings

For external use only. Do not use on wounds or damaged skin. Avoid contact with eyes or mucous membranes. If symptoms persist for more than 7 days, discontinue use and consult a physician.

Directions:

Adults and children 12 years of age and older: Apply directly to affected area. Do not use more than 4 times per day. Do not bandage damagedskin. Store at room temperature. Children under 12 years of age: ask a doctor.

Inactive Ingredients

Beeswax (organic), cotton seed oil, hemp extract (THC-free), jojoba seed oil, palmarosa oil, peppermint oil, silver oxide, sorbic acid, stearicacid (vegetable derived), tea tree oil, zinc oxide

* Please review the disclaimer below.