NDC 70335-310 Germisept Bran Antibacterial Moist

Benzalkonium Chloride

NDC Product Code 70335-310

NDC Code: 70335-310

Proprietary Name: Germisept Bran Antibacterial Moist Additional informationCallout TooltipWhat 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: Benzalkonium Chloride Additional informationCallout TooltipWhat 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.


Code Structure
  • 70335 - Innovent Inc.
    • 70335-310 - Germisept Bran Antibacterial Moist

NDC 70335-310-30

Package Description: 1 PACKAGE in 1 CARTON > 30 POUCH in 1 PACKAGE > 2.98 mL in 1 POUCH

NDC Product Information

Germisept Bran Antibacterial Moist with NDC 70335-310 is a a human over the counter drug product labeled by Innovent Inc.. The generic name of Germisept Bran Antibacterial Moist is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Innovent Inc.

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Germisept Bran Antibacterial Moist Active Ingredient(s)

Additional informationCallout TooltipWhat 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 1.15 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • BRONOPOL (UNII: 6PU1E16C9W)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Innovent Inc.
Labeler Code: 70335
FDA Application Number: part333E Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-10-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Germisept Bran Antibacterial Moist Product Label Images

Germisept Bran Antibacterial Moist 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 Ingredient

Benzalkonium Chloride 0.115%

Purpose

Antibacterial

Uses:

Decrease bacteria on the skin.

Warnings

  • For external use only.

When Using This Product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do Not Use

  • If irritation and redness develop.

Stop Use And Ask A Doctor

  • If condition persists for more than 72 hours.

Keep Out Of Reach Of Children/

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

Directions

  • Open resealable label, remove one wipe to use.Wipe hands thoroughly with product and allow to dry without wiping.Close resealable label after use to retain moisture.

Other Information

  • Store below 95° F (35° C) to prevent from drying out.Dispose of wipe in the proper container.Do not flush down the toilet.

Inactive Ingredients

2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.

* Please review the disclaimer below.

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