NDC | 69571-003-01, 69571-003-02 |
Set ID | bd3b8146-6271-488d-bf79-0bb659123b31 |
Category | HUMAN OTC DRUG LABEL |
Packager | FRONT PHARMACEUTICAL PLC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only.
Do not use
- if you are allergic to any of the ingredients in this product
- in contact with the eyes or mucous membranes
- over large areas of the body
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if
- symptoms persist for mroe than 7 days, the condition persists or gets worse
- symptoms clear up and then occur again within a few days
- a rash or other allergic reaction occurs
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- QUESTIONS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69571-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN .41 g in 100 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN .0035 g in 100 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B .52 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69571-003-02 1 in 1 BOX 02/22/2017 1 NDC:69571-003-01 28 g in 1 TUBE; 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 02/22/2017 Labeler - FRONT PHARMACEUTICAL PLC (530897792) Establishment Name Address ID/FEI Business Operations FRONT PHARMACEUTICAL PLC 530897792 manufacture(69571-003)