NDC 0363-6880 Walgreens Pain Relieving For Boils

Benzocaine

NDC Product Code 0363-6880

NDC 0363-6880-28

Package Description: 1 TUBE in 1 CARTON > 28 g in 1 TUBE

NDC Product Information

Walgreens Pain Relieving For Boils with NDC 0363-6880 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Pain Relieving For Boils is benzocaine. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 244557.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Walgreens Pain Relieving For Boils 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.

  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LANOLIN (UNII: 7EV65EAW6H)
  • MENTHOL (UNII: L7T10EIP3A)
  • THYMOL (UNII: 3J50XA376E)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Walgreen Company
Labeler Code: 0363
FDA Application Number: part333B 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 05-28-2014 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: 12-31-2021 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.

Walgreens Pain Relieving For Boils Product Label Images

Walgreens Pain Relieving For Boils 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

Otc - Active Ingredient

Active Ingredient                                                                           PurposeBenzocaine 20%----------------------------------------------------------- Pain Reliever

Otc - Purpose

Uses  For the temporary relief of pain and discomfort caused by boils

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use for more than 3 days

Otc - Ask Doctor

Ask a doctor before use if you have boils on the lips, nose, cheeks, or forehead

  • Stop use and ask a doctor iffever occursredness around the boil developscondition worsens or does not improvesymptoms persist for more than 3 dayssymptoms clear up and occur again within a few days

Otc - When Using

When using this product avoid contact with the eyes

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

DirectionsAdults and children 2 years of age and older            Apply to affected area no more than 2 times dailyChildren under 2 years of age                                 Consult a doctor

Storage And Handling

Other informationKeep carton for full drug facts

Inactive Ingredient

Inactive ingredients beeswax, camphor, eucalyptus oil, lanolin, menthol, thymol, white petrolatum

Dosage & Administration

Distributed by:Walgreen Co.200 Wilmot Rd.Deerfield, IL 60015 USAMade in Korea

* Please review the disclaimer below.