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Afassco triple antibiotic - Medication Information

Product NDC Code 51532-4605
Drug Name

Afassco triple antibiotic

Type Brand
Pharm Class Aminoglycoside Antibacterial [EPC],
Aminoglycosides [CS],
Decreased Cell Wall Synthesis & Repair [PE],
Polymyxin-class Antibacterial [EPC],
Polymyxins [CS]
Active Ingredients
Bacitracin zinc 400 [iu]/g
Neomycin sulfate 3.5 mg/g
Polymyxin b sulfate 5000 [iu]/g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 204602
Application Number part333B
Labeler Name Afassco Inc.
Packages
Package NDC Code Description
51532-4605-1 6 pouch in 1 box (51532-4605-1) / 1 g in 1 pouch
51532-4605-2 25 pouch in 1 box (51532-4605-2) / 1 g in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient (in each gram) Bacitracin Zinc 400 units Neomycin Sulfate (3.5mg Neomycin) Polymyxin B Sulfate 5000 units

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions ■ clean affected area ■ apply a small amount 1 to 3 times daily ■ may cover with a sterile bandage

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Petrolatum, Mineral Oil, Purified Water

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses first aid to help prevent infection in minor cuts, scrapes, and burns.

Purpose

Information about the drug product’s indications for use.
Purpose First Aid Antibiotics

Spl product data elements

Usually a list of ingredients in a drug product.
Afassco Triple Antibiotic BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE BACITRACIN ZINC BACITRACIN NEOMYCIN SULFATE NEOMYCIN POLYMYXIN B SULFATE POLYMYXIN B PETROLATUM MINERAL OIL WATER

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel Afassco¦ ¦ ® The First Choice in First Aid MAXIMUM STRENGTH TRIPLE ANTIBIOTIC OINTMENT UNIT DOSE - ANTI-INFECTION TRIPLE ACTION: BACITRACIN ZINC, NEOMYCIN & POLYMYXIN B. USE ON CUTS WHEN INFECTION IS EVIDENT. No. 331 6 ct. MAXIMUM STRENGTH TRIPLE ANTIBIOTIC OINTMENT 6 ct. MAXIMUM STRENGTH TRIPLE ANTIBIOTIC OINTMENT 6 ct. ​ ​ MAXIMUM STRENGTH ANTIBIOTIC OINTMENT (Bacitracin Zinc-Neomycin-Polymyxin B) First aid antibiotic plus topical pain reliever. NET WT. 1 gm ​Each gram contains 400 units of Bacitracin Zinc, Neomycin Sulfate equivalent to 3.5 mg of Neomycin base, 5000 units of Polymyxin B Sulfate in a white pertroleum base. INDICATIONS: First aid to help prevent infection and for the temporary relief of pain or discomfort i minor cuts, scrapes and burns. DIRECTIONS: Clean the affected area. Apply a small amount of this product (an amount equal to the tip of a finger) on on the area 1 to 3 daily. May be covered with sterile bandage. Children under 2 years of age consult a physician. LOT NO. & EXP DATE: Unit dose FOR EXTERNAL USE ONLY. NOT FOR OPTHALMIC USE. Store at controlled room temperature 15-30 C (59-86 F). WARNINGS: For external use only. DO NOT USE: Internally, in the eyes, over large aeas of the body or puncture wounds, animal bites or serious burns, for more than a week unless directed by a doctor or if you are allergic to any of the ingredients. ANTI-INFECCION CON TRIPLE ACCION UNA / AYUDA EN CURRAR LAS HERIDAS Solo para el uso topico, para ayudar en la prevencion de infecciones en las cortaduras menoras, quemadoras y abrasiones. INDICACIONES PARA EL USO : Apliquese a la area afectada 2 a 5 veces diariamente. No use en los ojos. Afassco¦ ¦ ® ANZI Z308.1 Manufactured for Afassco, Inc., Minden, NV 89423 6 ct, MAXIMUM STRENGTH TRIPLE ANTIBIOTIC OINTMENT 6 70254 20331 3 ↓Principal Display 6 ct. Package↓ ↓25 ct. Package↓ ↓Unit Dose Package↓ Afassco¦ ¦ ® The First Choice in First Aid Triple Antibiotic Ointment Manufactured for Afassco Minden, NV 89423 ​1 gm (1/32 oz) Made in China Triple Antibiotic Ointment by Afassco res Trpl Antibiotic Pack.jpg TripleOint 25ct-4605.jpg 51532-4605 6ct Box.jpg

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children If ingested, contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if ■ a rash or allergic reaction develops ■ condition worsens or persists

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only Do not use ■ internally ■ in eyes ■ over large areas of the body or on puncture wounds, animal bites or serious burns ■ for more than 1 week unless directed by a doctor ■ if you are allergic to any of the ingredients

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API