Label: AFASSCO TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
- NDC Code(s): 51532-4605-1, 51532-4605-2
- Packager: Afassco Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 12, 2023
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- Official Label (Printer Friendly)
- 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)