Label: ROOSIN NEOMYCIN ANTIBIOTIC- neomycin sulfate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 81552-001-01 - Packager: ROOSIN MEDICAL CO., LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated December 15, 2021
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- Active Ingredient
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROOSIN NEOMYCIN ANTIBIOTIC
neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81552-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 0.556 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) PARAFFIN (UNII: I9O0E3H2ZE) OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCEROL FORMAL (UNII: 3L7GR2604E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81552-001-01 0.9 g in 1 TUBE; Type 0: Not a Combination Product 04/12/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 04/12/2021 Labeler - ROOSIN MEDICAL CO., LTD (527587815) Establishment Name Address ID/FEI Business Operations ROOSIN MEDICAL CO., LTD 527587815 manufacture(81552-001)