Label: WATER-JEL 3-IN-1 ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
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NDC Code(s):
59898-740-01,
59898-740-02,
59898-740-03,
59898-740-34, view more59898-740-36, 59898-740-38
- Packager: Water-Jel Technologies
- 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 16, 2017
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- Active ingredients (each gram contains)
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INGREDIENTS AND APPEARANCE
WATER-JEL 3-IN-1 ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59898-740 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:59898-740-02 144 in 1 BOX, UNIT-DOSE 03/30/2010 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:59898-740-03 25 in 1 BOX, UNIT-DOSE 03/30/2010 2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:59898-740-01 1728 in 1 CARTON 03/30/2010 3 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:59898-740-38 1728 in 1 CARTON 03/30/2010 4 0.5 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC:59898-740-34 0.9 g in 1 PACKET; Type 0: Not a Combination Product 03/30/2010 6 NDC:59898-740-36 0.5 g in 1 PACKET; Type 0: Not a Combination Product 03/30/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/30/2010 Labeler - Water-Jel Technologies (155522589) Establishment Name Address ID/FEI Business Operations Water-Jel Technologies 155522589 manufacture(59898-740)