Label: MOLCHEM HAND PURIFIER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 80606-001-01, 80606-001-02, 80606-001-03, 80606-001-04, view more80606-001-05, 80606-001-06, 80606-001-07 - Packager: MOL BELTING SYSTEMS, INC
- 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 June 9, 2023
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INGREDIENTS AND APPEARANCE
MOLCHEM HAND PURIFIER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80606-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TRIETHYLENE GLYCOL (UNII: 3P5SU53360) PEG-75 LANOLIN (UNII: 09179OX7TB) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80606-001-01 59.14 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/15/2021 2 NDC:80606-001-02 236.58 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/15/2021 3 NDC:80606-001-03 3785.41 mL in 1 DRUM; Type 0: Not a Combination Product 07/15/2021 4 NDC:80606-001-04 18927.1 mL in 1 DRUM; Type 0: Not a Combination Product 07/15/2021 5 NDC:80606-001-05 208198 mL in 1 DRUM; Type 0: Not a Combination Product 07/15/2021 6 NDC:80606-001-06 1040987.75 mL in 1 JUG; Type 0: Not a Combination Product 07/15/2021 7 NDC:80606-001-07 500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 07/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/15/2021 Labeler - MOL BELTING SYSTEMS, INC (147753685) Establishment Name Address ID/FEI Business Operations Mol Belting Systems Inc 147753685 pack(80606-001)