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Drug Facts
Afassco Triple Antibiotic
FDA Label NDC 51532-4605
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Afassco Inc. for the product Afassco Triple Antibiotic (NDC 51532-4605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredient (in each gram)
Bacitracin Zinc 400 units
Neomycin Sulfate (3.5mg Neomycin)
Polymyxin B Sulfate 5000 units
Otc - Purpose
Purpose
First Aid Antibiotics
Indications & Usage
Uses first aid to help prevent
infection in minor cuts,
scrapes, and burns.
Warnings
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
Otc - Stop Use
Stop use and ask a doctor if
■ a rash or allergic reaction
develops ■ condition worsens
or persists
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If ingested, contact a Poison
Control Center right away.
Dosage & Administration
Directions ■ clean affected
area ■ apply a small amount
1 to 3 times daily ■ may cover
with a sterile bandage
Inactive Ingredient
Inactive Ingredients
Petrolatum, Mineral Oil,
Purified Water
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 gmEach 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
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