Label: TRIPLE ANTIBIOTIC- polymyxin b sulfate,neomycin sulfate,bacitracin ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 82199-530-11, 82199-530-12 - Packager: Shandong Ruian Pharmaceutical Co.,Ltd.
- 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 13, 2021
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- WARNINGS
- INACTIVE INGREDIENT
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- ASK DOCTOR
- ACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
polymyxin b sulfate,neomycin sulfate,bacitracin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82199-530 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 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3500 [USP'U] in 1 g BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color yellow (YELLOW (Translucent)) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82199-530-11 14.2 g in 1 TUBE; Type 0: Not a Combination Product 08/26/2021 2 NDC:82199-530-12 28.3 g in 1 TUBE; Type 0: Not a Combination Product 08/26/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/26/2021 Labeler - Shandong Ruian Pharmaceutical Co.,Ltd. (723845363)