NDC 72663-161 Welly Bravery Triple Antibiotic With Pain Relief

Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hcl

NDC Product Code 72663-161

NDC Code: 72663-161

Proprietary Name: Welly Bravery Triple Antibiotic With Pain Relief Additional informationCallout TooltipWhat 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: Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate, Pramoxine Hcl Additional informationCallout TooltipWhat 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.


Code Structure
  • 72663 - Welly Health Pbc
    • 72663-161 - Welly Bravery Triple Antibiotic With Pain Relief

NDC 72663-161-60

Package Description: 2 TUBE in 1 CASE > 14 g in 1 TUBE

NDC Product Information

Welly Bravery Triple Antibiotic With Pain Relief with NDC 72663-161 is a a human over the counter drug product labeled by Welly Health Pbc. The generic name of Welly Bravery Triple Antibiotic With Pain Relief is bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Welly Health Pbc

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 Additional informationCallout TooltipWhat 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.


Welly Bravery Triple Antibiotic With Pain Relief Active Ingredient(s)

Additional informationCallout TooltipWhat 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
  • POLYMYXIN B SULFATE 10000 [USP'U]/g
  • NEOMYCIN SULFATE 3.5 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • PETROLATUM (UNII: 4T6H12BN9U)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Welly Health Pbc
Labeler Code: 72663
FDA Application Number: part333B Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Welly Bravery Triple Antibiotic With Pain Relief Product Label Images

Welly Bravery Triple Antibiotic With Pain Relief 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

Active Ingredients (In Each Gram)

Bacitracin 500Neomycin 3.5 mgPolymyxin B 10,000 unitsPramoxine HCL 10 mg/g

Purpose

First aid antibioticFirst aid antibioticFirst aid antibioticPain reliever

Uses

  • First aid to help prevent infection and temporarily relieves pain due to minor:cutsscrapesburns

Warnings

For external use only

Allergy Alert:

  • Do not use if you are allergic to any of the ingredients

Do Not Use

  • In or near the eyes
  • On large areas of the body

Consult A Doctor Before Use If You Have

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

When Using This Product

  • Do not use longer than 1 week

Stop Use And Consult A Doctor If

  • Condition persists or gets worse
  • Symptoms last for more than 7 days or clear up and come back within a few days
  • A rash or other allergic reaction develops

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 immediately.

Directions

  • Adults and children 2 years of age and olderclean the affected areaapply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.may be covered with a sterile bandageChildren under 2 years of age; ask a doctor

Other Information

  • Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive Ingredient

Petrolatum

Principal Dispaly Panel -Tube

Welly First aid NDC 72663-161-60Triple Action First Aid Antibiotic & Pain Relieving Ointment  NET WT 0.5 oz (14g)Bacitracin Zinc, Neomycin Sulfate, Polymixin B Sulfat, Pramoxine HCL

* Please review the disclaimer below.

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