NDC 69148-001 Arc Skin Protectant
Allantoin Ointment Topical

Product Information

Product Code69148-001
Proprietary Name 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.
Arc Skin Protectant
Non-Proprietary Name 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.
Allantoin
Product Type 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.
Human Otc Drug
Dosage FormOintment - 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.
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.
Anjon Biologics, Inc
Labeler Code69148
FDA Application Number 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.
part347
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-06-2014
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 69148-001-00

Package Description: 118.6 g in 1 TUBE

NDC 69148-001-01

Package Description: 60 g in 1 TUBE

Product Details

Arc Skin Protectant is a human over the counter drug product labeled by Anjon Biologics, Inc. The generic name of Arc Skin Protectant is allantoin. The product's dosage form is ointment and is administered via topical form.


What are Arc Skin Protectant Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • IMIDUREA (UNII: M629807ATL)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • JOJOBA OIL (UNII: 724GKU717M)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • WATER (UNII: 059QF0KO0R)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SORBITAN TRISTEARATE (UNII: 6LUM696811)
  • VITAMIN A (UNII: 81G40H8B0T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)


* Please review the disclaimer below.

Arc Skin Protectant Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Arc Skin Protectant Ointment





Active Ingredient / Purpose





Otc - Purpose



Allantoin 0.5% .............................. Skin Protectant


Use



  • temporarily protects minor burns

Warnings



For external use only


Do not use on
  • deep or puncture wounds
  • animal bites
  • serious burns
  • 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
      • your skin shows significant sign of irritation or discomfort


Otc - Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



Apply as needed


Other Information



  • Keep in a cool place or out of direct sunlight

Inactive Ingredients



aloe vera leaf gel, benzoic acid, benzyl alcohol, cetyl alcohol, citric acid, coconut oil, glycenn, imidazolidinyl urea, isopropyl mylistate, jojoba seed oil, methylisothiazolinone, mineral water, shea butter, sorbitan histearate, vitamin A, vitamin E acetate


Questions Or Comments?



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* Please review the disclaimer below.