NDC 69968-0728 Band Aid Antiseptic Cleansing

Benzalkonium Chloride

NDC Product Code 69968-0728

NDC 69968-0728-1

Package Description: 68 mL in 1 BOTTLE, PUMP

NDC Product Information

Band Aid Antiseptic Cleansing with NDC 69968-0728 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Band Aid Antiseptic Cleansing is benzalkonium chloride. The product's dosage form is aerosol, foam and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1020365.

Dosage Form: Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.

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.

Band Aid Antiseptic Cleansing 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.


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)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Johnson & Johnson Consumer Inc.
Labeler Code: 69968
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: 12-29-2021 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 - NO 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".

* Please review the disclaimer below.

Band Aid Antiseptic Cleansing Product Label Images

Band Aid Antiseptic Cleansing 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 Facts

Distributed by:


JOHNSON & JOHNSON CONSUMER INC.Skillman, NJ 08558

Active Ingredient

Benzalkonium Cl (0.13%)

Purposes

First aid antiseptic

Use

First aid to help prevent infection in minor: · cuts · scrapes · burns

Warnings

  • For external use only.

Otc - Do Not Use

Do not use · in the eyes · over large area of the body · longer than 1 week

Otc - Ask Doctor

  • Ask a doctor before use if you have · deep or puncture wounds · animal bites · serious burns

Otc - Stop Use

  • Stop use and ask a doctor if the condition persists or gets worse

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: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

if bandaged, let dry first
children under 2 years of age: consult a doctor

Other Information

Protect from freezing

Inactive Ingredients

Water, Poloxamer 188, Sodium Chloride, Disodium EDTA, Sodium Hydroxide, Aloe Barbadensis Leaf Juice, Citric Acid

Questions?

Call 800-526-3967 or 215-273-8755 (collect).

* Please review the disclaimer below.