NDC 63347-900 Eudermis Rx

Benzalkonium Chloride

NDC Product Code 63347-900

NDC 63347-900-01

Package Description: 88.7 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Eudermis Rx with NDC 63347-900 is a a human prescription drug product labeled by Blaine Labs Inc.. The generic name of Eudermis Rx is benzalkonium chloride. The product's dosage form is gel and is administered via topical form.

Labeler Name: Blaine Labs Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Prescription 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.

Eudermis Rx 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.

  • BENZALKONIUM CHLORIDE .0887 g/88.7mL

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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • EGG SHELL MEMBRANE (UNII: N7QBR4212V)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)

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: Blaine Labs Inc.
Labeler Code: 63347
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-01-2019 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.

Eudermis Rx Product Label Images

Eudermis Rx 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

Other

DRUG FACTSACTIVE INGREDIENT ................................. PURPOSEBENZALKONIUM CHLORIDE 0.1% ........... ANTIMICROBIAL

Indications & Usage

  • INDICATIONSFOR MANAGEMET OF STAGE 1-IV PRESSURE ULCERS, STASIS ULCERS,DIABETIC SKIN ULCERS, POST-SURGICAL INCISIONS, FIRST ANDSECOND-DEGREE BURNS, CUTS, ABRASIONS AND SKIN IRRITATIONS.

Warnings

WARNINGSFOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES; RINSEIMMEDIATELY WITH COOL TAP WATER IF CONTACT OCCURS.DO NOT USE MORE THATN THE RECOMMENDED DOSE OR LONGERTHAN PRESCRIBED WITHOUT CHECKING WITH YOUR PHYSICIAN.TALK WITH YOUR PHYSICIAN BEFORE YOU USE ANY OTHER MEDICINESOR CLEANSERS ON YOUR SKIN. ASK YOUR PHYSICIAN BEFOREPROLONGED SUN EXPOSURE. IF YOUR SYMPTOMS DO NOTIMPROVE OR IF THEY WORSEN, CONTACT YOUR PHYSICIAN.

Other Safety Information

KEEP OUT OF REACH OF CHILDRENIF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISONCONTROL CENTER IMMEDIATELY.

CONTAINS EGGSHELL MEMBRANE POWDER - A NON-ALLERGENICORGANIC SOURCE OF SOLUBILIZED PROTEIN TISSUE GROWTHFACTORS INCLUDING COLLAGEN, ELASTIN, HYALURONIC ACID,EIGHT ESSENTIAL AMINO ACIDS AND TRANSFORMINGGROWTH FACTOR - b.

Dosage & Administration

DIRECTIONSCLEAN THE WOUND BEFORE EACH APPLICATION. APPLY A THINLAYER OF EUDERMIS® WOUND CARE GEL TO THE WOUNDSURFACE AND SKIN IMMEDIATELY SURROUNDING THE WOUND.COVER THE WOUND AS DIRECTED BY YOUR PHYSICIAN.

Product Package

BY PRESRIPTION ONLYBLAINE LABS®EUDERMIS®WOUND CARE GELBENZALKONIUM CHLORIDEIN A GEL CONTAININGTRANSFORMING GROWTH FACTOR - ß3.0 FL OZ (88.7 mL)MANUFACTURED BY:                                 QUESTIONS OR COMMENTS?BLAINE LABS, INC.                                    CALL 800.307.881811037 LOCKPORT PLACE M-F,                 8AM-5PM (PST)SANTA FE SPRINGS, CA 90670REV20190215                                                                  80000-01-TB01res

* Please review the disclaimer below.

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