Label: FIRST AID ONLY TRIPLE ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 0924-5605-01, 0924-5605-02, 0924-5605-03, 0924-5605-04, view more0924-5605-05, 0924-5605-06, 0924-5605-07 - Packager: Acme united 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 November 12, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
Warnings
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 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredient
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
FIRST AID ONLY TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5605 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 417.8 [iU] in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5322.8 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-5605-07 144 in 1 BOX, UNIT-DOSE 11/12/2019 1 0.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-5605-05 25 in 1 BOX, UNIT-DOSE 11/12/2019 2 0.5 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-5605-06 60 in 1 CARTON 11/12/2019 3 0.5 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:0924-5605-04 12 in 1 CARTON 11/12/2019 4 0.5 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC:0924-5605-03 10 in 1 CARTON 11/12/2019 5 0.5 g in 1 PACKET; Type 0: Not a Combination Product 6 NDC:0924-5605-01 0.5 g in 1 PACKET; Type 0: Not a Combination Product 11/12/2019 7 NDC:0924-5605-02 6 in 1 BAG 11/12/2019 7 0.5 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 11/12/2019 Labeler - Acme united Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-5605) , repack(0924-5605) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-5605) , repack(0924-5605) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(0924-5605)