Label: BACITRACIN ZINC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 58980-012-01
- Packager: STRATUS PHARMACEUTICALS INC
- 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.
Updated November 2, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredient (in each gram) Purpose Bacitracin zinc 500 units First aid antibiotic Polymyxin B 10,000 units First aid antibiotic
First aid to help prevent infection in
- minor cuts
For external use only
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if
- condition persists or gets worse
- a rash or other allergic reaction develops
- Clean the affected area
- Apply a small amount of this product on the area 1 to 3 times
- May be covered with a sterile bandage
- Other information
- Store at room temperature
- Before using any medication, read all label directions.
- Inactive ingredient
- Questions or comments?
Call toll-free 1-800-442-7882Close
- SPL UNCLASSIFIED SECTION
Distributed by: Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186Close
- PRINCIPAL DISPLAY PANEL - 0.9 g Packet Box
(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)
First Aid Antibiotic
Net Wt. 0.9g (1/32 oz) PACKETTES
- INGREDIENTS AND APPEARANCE
bacitracin zinc and polymyxin b sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (OFF WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-012-01 144 in 1 BOX 09/15/2017 1 0.9 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 09/15/2017 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-012) , LABEL(58980-012) , PACK(58980-012)