Label: SCHEIN BACITRACIN- bacitracin zinc ointment
- NDC Code(s): 0404-0400-09, 0404-0400-28, 0404-0400-47, 0404-0400-48
- Packager: Henry Schein, 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.
Drug Label Information
Updated January 3, 2023
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- ACTIVE INGREDIENT
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
DO NOT USE: In the eyes. Over large areas of the body. If you are allergic to any of the ingredients due to the possibility of anaphylactic shock. Longer than 1 week unless directed by a doctor.
Stop use and ask a doctor before use: in the case of dep puncture wounds, animal bites, or serious burns. If the condition persists or gets worse. If a rash or other allergic reaction develops.
If swallowed get medical help or contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
bacitracin zinc ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0404-0400-47 144 in 1 CARTON 12/04/2011 1 NDC:0404-0400-09 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0404-0400-48 1 in 1 CARTON 12/04/2011 2 NDC:0404-0400-28 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 M004 12/04/2011 01/01/2024 Labeler - Henry Schein, Inc. (012430880) Registrant - ULTRAtab Laboratories, Inc. (151051757) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(0404-0400) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(0404-0400) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 944090448 pack(0404-0400)