NDC 69968-0221 Band-aid Brand Hurt-free Antiseptic Pain Relieving

Benzalkonium Chloride And Lidocaine Hydrochloride

NDC Product Code 69968-0221

NDC CODE: 69968-0221

Proprietary Name: Band-aid Brand Hurt-free Antiseptic Pain Relieving What 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 What 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.

NDC Code Structure

  • 69968 - Johnson & Johnson Consumer Inc.
    • 69968-0221 - Band-aid Brand Hurt-free Antiseptic Pain Relieving

NDC 69968-0221-6

Package Description: 177 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Band-aid Brand Hurt-free Antiseptic Pain Relieving with NDC 69968-0221 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Band-aid Brand Hurt-free Antiseptic Pain Relieving is benzalkonium chloride and lidocaine hydrochloride. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1012081 and 1235022.

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.

Band-aid Brand Hurt-free Antiseptic Pain Relieving 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.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • 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.

  • 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: 12-14-2011 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 Brand Hurt-free Antiseptic Pain Relieving Product Label Images

Band-aid Brand Hurt-free Antiseptic Pain Relieving 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

Otc - Purpose

Active ingredientsPurposeBenzalkonium Cl 0.13%First aid antisepticLidocaine HCl 2% w/wTopical analgesic

Uses

  • First aid to help prevent infection and temporarily relieve pain or discomfort in minor:cutsscrapesburns

Warnings

For external use only

Do Not Use

  • In the eyesover large areas of the bodyin large quantities, particularly over raw surfaces or blistered areas.

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

  • Condition or symptoms get worse or last more than 1 weeksymptoms clear up and occur again within a few days

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 areaapply a small amount of this product on the area 1 to 3 times dailymay be covered with a sterile bandageif bandaged, let dry firstchildren under 2 years of age: consult a doctor

Other Information

  • Store at room temperature

Inactive Ingredients

Aloe barbadensis leaf juice, disodium EDTA, poloxamer 188, sodium chloride, sodium citrate, water

Questions?

Call toll-free 866-565-2873 or 215-273-8755 (collect)

* Please review the disclaimer below.