FDA Label for Afassco Triple Antibiotic

View Indications, Usage & Precautions

Afassco Triple Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Afassco Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


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 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


* Please review the disclaimer below.