NDC | 50332-0032-1, 50332-0032-2, 50332-0032-3, 50332-0032-4, 50332-0032-5, 50332-0032-6 |
Set ID | d8f175f9-f526-4c73-a171-49309ca16cb0 |
Category | HUMAN OTC DRUG LABEL |
Packager | HART Health |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ADVERSE REACTIONS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions:
Do not use more than directed.
Adults and children 12 years of age and over:
- clean the affected area
- apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Children under 12 years of age: ask a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0032 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0032-6 10 in 1 BOX, UNIT-DOSE 10/03/2005 1 .5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:50332-0032-3 25 in 1 BOX, UNIT-DOSE 10/03/2005 2 .5 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:50332-0032-5 144 in 1 BOX, UNIT-DOSE 10/03/2005 3 .5 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:50332-0032-1 10 in 1 BOX, UNIT-DOSE 10/03/2005 4 .9 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC:50332-0032-2 25 in 1 BOX, UNIT-DOSE 10/03/2005 5 .9 g in 1 PACKET; Type 0: Not a Combination Product 6 NDC:50332-0032-4 144 in 1 BOX, UNIT-DOSE 10/03/2005 6 .9 g in 1 PACKET; 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 10/03/2005 Labeler - HART Health (069560969)