Label: POLY BACITRACIN- first aid antibiotic ointment ointment
- NDC Code(s): 70000-0471-1
- Packager: Cardinal Health
- 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 March 6, 2019
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- Active Ingredient
- Active Ingredients
For external use only
Do not use
in the eyes, over large areas of the body, if you are allergic to any of the ingredients, longer than one week
Stop use and ask a doctor if
you need to use longer than one week, condition persists or gets worse, rash or other allergic reaction develops
- Other Information
- Inactive Ingredients
- Questions and comments?
INGREDIENTS AND APPEARANCE
first aid antibiotic ointment ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0471 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0471-1 72 in 1 CASE 11/20/2018 1 1 in 1 BOX 1 28.4 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 11/20/2018 Labeler - Cardinal Health (097537435) Registrant - Dynarex Corporation (008124539)