NDC 65197-820 Bactine Max

Bactine Max Wound Wash

NDC Product Code 65197-820

NDC 65197-820-80

Package Description: 1 BOTTLE in 1 CARTON > 236 mL in 1 BOTTLE

NDC Product Information

Bactine Max with NDC 65197-820 is a a human over the counter drug product labeled by Wellspring Pharmaceutical Corporation. The generic name of Bactine Max is bactine max wound wash. The product's dosage form is liquid and is administered via cutaneous form.

Labeler Name: Wellspring Pharmaceutical Corporation

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Bactine Max 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 .13 g/100mL

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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Cutaneous - Administration to the skin.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wellspring Pharmaceutical Corporation
Labeler Code: 65197
FDA Application Number: part333A 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: 01-15-2021 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 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.

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

Active Ingredient

Benzalkonium Cl 0.13% w/w

Purpose

First aid antiseptic

Use

First aid to help prevent bacterial contamination or skin infection in minor cuts, scrapes and burns.

Warning

For external use only. Do not use on or near the eyes. Do not apply to large areas of the body. Ask a doctor before use if -you have - deep or puncture wounds - animal bites - serious burns. Stop use and ask doctor if - condition persists or get worse - symptoms persist for more than 7 days.

Directions

Clean the affected area, apply a small amount of this product on the area 1 to 3 times daily; may be covered with a sterile bandage (let dry first).

Other Information

Avoid excessive heat

Inactive Ingredients

Aloe barbadensis leaf extract, edetate disodium, nonoxynol 9, PEG-100 Stearate, propylene glycol, purified water

Questions?

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

Bactine Wound Wash Label

Bactine Wound Wash Label

* Please review the disclaimer below.