Label: TRIPLE ANTIBIOTIC- polymyxin b sulfate, bacitracin zinc and neomycin sulfate ointment
- NDC Code(s): 50090-0234-0
- Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 0713-0268
- 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 March 6, 2023
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- Official Label (Printer Friendly)
- 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 - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- HOW SUPPLIED
- TRIPLE ANTIBIOTIC OINTMENT
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
polymyxin b sulfate, bacitracin zinc and neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-0234(NDC:0713-0268) 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 5000 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] 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:50090-0234-0 28.4 g in 1 TUBE; Type 0: Not a Combination Product 11/28/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/11/1995 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-0234)