Label: CARING MILLS TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
- NDC Code(s): 71101-801-01
- Packager: Veridian Healthcare
- 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 May 16, 2023
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- Active Ingredients
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- Inactive ingredients
- Caring Mills Triple Antibiotic Ointment
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INGREDIENTS AND APPEARANCE
CARING MILLS TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71101-801 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) PARAFFIN (UNII: I9O0E3H2ZE) COCOA BUTTER (UNII: 512OYT1CRR) COTTONSEED OIL (UNII: H3E878020N) OLIVE OIL (UNII: 6UYK2W1W1E) SODIUM PYRUVATE (UNII: POD38AIF08) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71101-801-01 1 in 1 CARTON 05/01/2023 1 56.6 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 05/01/2023 Labeler - Veridian Healthcare (830437997) Establishment Name Address ID/FEI Business Operations ANICARE PHARMACEUTICALS PRIVATE LIMITED 916837425 manufacture(71101-801)