Label: HAND ARMOR- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58590-001-01, 58590-001-02, 58590-001-03 - Packager: HyGenesis
- 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 October 15, 2021
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INGREDIENTS AND APPEARANCE
HAND ARMOR
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58590-001 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 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4) PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58590-001-01 21.26 g in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2013 2 NDC:58590-001-02 85.05 g in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2013 3 NDC:58590-001-03 170.1 g in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/04/2013 Labeler - HyGenesis (039503442) Establishment Name Address ID/FEI Business Operations Elba, Inc. 108428483 manufacture(58590-001) , label(58590-001) , pack(58590-001)
