Label: PROPLEX BACITRACIN- bacitracin cream
- NDC Code(s): 67234-059-01
- Packager: Natureplex LLC
- 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 January 12, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive ingredient
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- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
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INGREDIENTS AND APPEARANCE
PROPLEX BACITRACIN
bacitracin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67234-059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 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:67234-059-01 1 in 1 CARTON 03/18/2019 1 28 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 03/18/2019 Labeler - Natureplex LLC (062808196) Establishment Name Address ID/FEI Business Operations Natureplex LLC 062808196 MANUFACTURE(67234-059)