Label: BACITRACIN ZINC ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 67777-220-01, 67777-220-02, 67777-220-03, 67777-220-04, view more67777-220-05, 67777-220-07 - Packager: Dynarex Corporation
- 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 June 15, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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Warnings:
For external use only
DOSAGE & ADMINISTRATION:
- clean the affected areas, Apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily. May be covered with a sterile bandage
Stop use and ask a doctor if
Stop use and ask a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops.
- Purpose:
- Other information
- Ask a doctor if
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BACITRACIN ZINC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67777-220 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 Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) LIGHT MINERAL OIL (UNII: N6K5787QVP) MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67777-220-02 28.35 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2009 2 NDC:67777-220-03 14.17 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2009 3 NDC:67777-220-04 113.4 g in 1 TUBE; Type 0: Not a Combination Product 12/01/2009 4 NDC:67777-220-07 425.3 g in 1 JAR; Type 0: Not a Combination Product 12/01/2009 5 NDC:67777-220-05 0.5 g in 1 PACKET; Type 0: Not a Combination Product 12/01/2009 6 NDC:67777-220-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 12/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 12/01/2009 Labeler - Dynarex Corporation (008124539) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Pvt. Ltd. 864201135 manufacture(67777-220) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Private Limited 650970176 manufacture(67777-220)