Label: SAFETY CLEAR ANTIBACTERIAL HAND- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 22431-587-01, 22431-587-02, 22431-587-03 - Packager: Blue Cross Laboratories, 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 August 26, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SAFETY CLEAR ANTIBACTERIAL HAND
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:22431-587 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CHLORIDE (UNII: 451W47IQ8X) DMDM HYDANTOIN (UNII: BYR0546TOW) WATER (UNII: 059QF0KO0R) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:22431-587-01 236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2020 2 NDC:22431-587-02 1180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2020 3 NDC:22431-587-03 444 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/25/2020 Labeler - Blue Cross Laboratories, Inc (008298879) Establishment Name Address ID/FEI Business Operations Blue Cross Laboratories 008298879 manufacture(22431-587)