NDC 58518-040 Barrier Cream

Zinc Oxide

NDC Product Information

Barrier Cream with NDC 58518-040 is a a human over the counter drug product labeled by Avasol Llc. The generic name of Barrier Cream is zinc oxide. The product's dosage form is cream and is administered via topical form.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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.

Barrier Cream 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.


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.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • JOJOBA OIL (UNII: 724GKU717M)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • ORANGE PEEL WAX (UNII: 0U715N387C)
  • ASTAXANTHIN (UNII: 8XPW32PR7I)
  • BENTONITE (UNII: A3N5ZCN45C)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ROSEMARY (UNII: IJ67X351P9)
  • ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
  • ST. JOHN'S WORT (UNII: UFH8805FKA)
  • CHAMOMILE (UNII: FGL3685T2X)
  • LICORICE (UNII: 61ZBX54883)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • MANUKA OIL (UNII: M6QU9ZUH2X)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

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: Avasol Llc
Labeler Code: 58518
FDA Application Number: part352 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: 01-01-2022 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Barrier Cream 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

Zinc Oxide (Non-nano) 10%

Purpose

Skin protectant

Uses

  • Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness.
  • Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Warnings

  • For external use onlyAvoid contact with eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

  • Condition worsens
  • Symptoms last for more than 7 days or clear up and occur again within a few days

Otc - Do Not Use

  • Do not use:if allergic to ingredients.
  • On deep or puncture wounds
  • On animal bites •on serious burns.
  • Test small area first.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally, directly on skin as needed. May be applied to prosthetics, protective equipment, etc. Will solidify at cold temps. Warm and knead as required.

Inactive Ingredients

*Caprylic/Capric Triglyceride (Fractionated Coconut Oil), *Cocos Nucifera (Coconut) Oil, *Cera Alba (beeswax), **Euphorbia Cerifera (candelilla) wax, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol, Olea Europaea (Olive) Leaf Extract, Citrus Aurantium Dulcis Peel Cera, Astaxanthin, Bentonite, Cetearyl Olivate, Sorbitan Olivate, *Propolis, *Lavandula Angustifolia (Lavender) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract,*Aloe barbadensis,*St. John's wort (Hypericum perforatum),*Chamomile (Matricaria chamomilla L), *Licorice Root (Glycyrrhiza glabra), *Calendula Officinalis Flower Extract, **Leptospermum scoparium (Manuka) Oil, *Mentha Piperita (Peppermint) Oil *Organic **Wildcrafted

Other Information

Protect from freezing. Avoid excessive heat.

Questions?

Call 888-805-1507 or visit www.avasol.com

* Please review the disclaimer below.