NDC 0295-9009 Bactine Max

Benzalkonium Chloride And Lidocaine Hydrochloride

NDC Product Code 0295-9009

NDC Code: 0295-9009

Proprietary Name: Bactine Max 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 And Lidocaine Hydrochloride 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
  • 0295 - Denison Pharmaceuticals, Llc
    • 0295-9009 - Bactine Max

NDC 0295-9009-17

Package Description: 118 mL in 1 BOTTLE

NDC 0295-9009-55

Package Description: 148 mL in 1 BOTTLE

NDC Product Information

Bactine Max with NDC 0295-9009 is a a human over the counter drug product labeled by Denison Pharmaceuticals, Llc. The generic name of Bactine Max is benzalkonium chloride and lidocaine hydrochloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Denison Pharmaceuticals, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.


Bactine Max 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 .13 g/100mL
  • LIDOCAINE HYDROCHLORIDE 4 g/100mL

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Denison Pharmaceuticals, Llc
Labeler Code: 0295
FDA Application Number: part333A 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: 03-08-2019 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.

Bactine Max Product Label Images

Bactine Max 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

Uses

  • First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor:cutsscrapesminor burnssunburnminor skin irritations

Warnings

For external use only

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

When Using This Product

  • Do not use in or near the eyesdo not apply over large areas of the body or in large quantitiesdo not apply over raw surfaces or blistered areas

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persist for more than 7 days, or clear up and occur again within a few days

Directions

  • Adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)children under 2 years, ask a doctor

Other Information

Avoid excessive heat

Inactive Ingredients

Edetate disodium, fragrances, nonoxynol 9, propylene glycol, purified water

Questions?

1-844-241-5454  Mon-Fri (8-5 EST) or www.bactine.com

* Please review the disclaimer below.

Previous Code
0295-9008
Next Code
0295-9032