NDC | 50332-0031-0, 50332-0031-2 |
Set ID | b5725d7a-2a46-415a-9b90-33dd52439217 |
Category | HUMAN OTC DRUG LABEL |
Packager | HART Health |
Generic Name | |
Product Class | Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic |
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
TRIBIOTICLC LC LC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50332-0031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 in 1 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50332-0031-2 25 in 1 BOX, UNIT-DOSE 1 NDC:50332-0031-0 .5 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 05/04/2012 Labeler - HART Health (069560969)