Label: BIOMIRACLE STAYSAFE ANTIBACTERIAL HANDSOAP- chloroxylenol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 77978-525-01 - Packager: MJM SOURCING, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 27, 2020
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BIOMIRACLE STAYSAFE ANTIBACTERIAL HANDSOAP
chloroxylenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77978-525 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 1.25 g in 500 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) GLYCOL STEARATE (UNII: 0324G66D0E) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) COCO MONOETHANOLAMIDE (UNII: C80684146D) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 4 (UNII: X3W0AM1JLX) SODIUM CHLORIDE (UNII: 451W47IQ8X) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77978-525-01 500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/27/2020 Labeler - MJM SOURCING, LLC (078861054) Establishment Name Address ID/FEI Business Operations Panrosa Enterprises, Inc. 859957578 manufacture(77978-525)
