NDC | 0713-0622-31 |
Set ID | 69d911c2-cb89-2241-35f8-c83acfe18249 |
Category | HUMAN OTC DRUG LABEL |
Packager | G&W Laboratories, Inc. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT (in each gram)
- PURPOSE
- USES
-
WARNINGS
For external use only.
Do not use
• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body
• longer than 1 week unless directed by a doctor.
Ask a doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns
Stop use and ask a doctor if
• the condition persists or gets worse
• a rash or other allergic reaction develops
• symptoms persist for more than 1 week, or clear up and occur again within a few days - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC PLUS
polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0713-0622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B Sulfate 10000 [USP'U] in 1 g Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc 500 [USP'U] in 1 g Neomycin (UNII: I16QD7X297) (Neomycin - UNII:I16QD7X297) Neomycin 3.5 mg in 1 g Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Light Mineral Oil (UNII: N6K5787QVP) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0713-0622-31 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 02/28/1998 Labeler - G&W Laboratories, Inc. (001271188) Registrant - G&W Laboratories, Inc. (001271188) Establishment Name Address ID/FEI Business Operations G&W Laboratories, Inc. 001271188 MANUFACTURE