NDC | 51532-4605-1, 51532-4605-2 |
Set ID | ed1e3b2f-f6ad-4b18-956e-66f817403007 |
Category | HUMAN OTC DRUG LABEL |
Packager | Afassco Inc. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
-
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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INGREDIENTS AND APPEARANCE
AFASSCO TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51532-4605 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51532-4605-1 6 in 1 BOX 12/07/2018 1 1 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:51532-4605-2 25 in 1 BOX 12/07/2018 2 1 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 12/07/2018 Labeler - Afassco Inc. (609982723) Registrant - Afassco Inc. (956159800)