NDC 73014-3035 Ancalima Bacitracin Zinc First Aid

Bacitracin Zinc

NDC Product Code 73014-3035

NDC 73014-3035-2

Package Description: .9 g in 1 PACKET

NDC 73014-3035-3

Package Description: 14 g in 1 TUBE

NDC 73014-3035-4

Package Description: 28 g in 1 TUBE

NDC 73014-3035-5

Package Description: 113 g in 1 TUBE

NDC 73014-3035-6

Package Description: 425 g in 1 JAR

NDC Product Information

Ancalima Bacitracin Zinc First Aid with NDC 73014-3035 is a a human over the counter drug product labeled by Ancalima Lifesciences Limited. The generic name of Ancalima Bacitracin Zinc First Aid is bacitracin zinc. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Ancalima Lifesciences Limited

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.


Ancalima Bacitracin Zinc First Aid 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.

  • BACITRACIN ZINC 500 [USP'U]/g

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.

  • PARAFFIN (UNII: I9O0E3H2ZE)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • LANOLIN (UNII: 7EV65EAW6H)

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: Ancalima Lifesciences Limited
Labeler Code: 73014
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: 04-08-2019 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: 12-31-2020 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.

Ancalima Bacitracin Zinc First Aid Product Label Images

Ancalima Bacitracin Zinc First Aid 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 (In Each Gram)

Bacitracin Zinc (equal to 500 bacitracin units)

Purpose

First Aid Antibiotic

Uses

■ first aid to help prevent infection in minor ■ cuts ■ scrapes ■ burns

Warnings

For external use only

Do Not Use

■ Not for opthalmic use
Do not use ■ in the eyes ■ if you are allergic to any of the ingredients ■ over large areas of the body longer than 1 week unless directed by a doctor

Ask A Doctor Before Use In Case Of

■ deep or puncture wounds■ animal bites ■ serious burns

Stop Use And Ask A Doctor If

■ the condition persists or gets worse■ a rash or other allergic reaction develops

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

■ clean the affected area■ apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
•may be covered with a sterile bandage

Other Information

■ store at room temperature 15-30C (59-86F)■ avoid excessive heat and humidity

Inactive Ingredients

Hard paraffin, liquid paraffin, white soft paraffin, lanolin

* Please review the disclaimer below.

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