Label: I.C. HAND SANITIZER- benzalkonium chloride aerosol, foam
- NDC Code(s): 59555-401-11, 59555-401-12, 59555-401-13
- Packager: R&R Lotion, 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 February 11, 2022
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- Official Label (Printer Friendly)
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- Active Ingredient
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- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL - 591 ML Bottle Label
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INGREDIENTS AND APPEARANCE
I.C. HAND SANITIZER
benzalkonium chloride aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59555-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetrimonium Chloride (UNII: UC9PE95IBP) Laurtrimonium Chloride (UNII: A81MSI0FIC) Dihydroxyethyl Cocamine Oxide (UNII: 8AR51R3BL5) Glycereth-17 Cocoate (UNII: 3057VPT0KC) Citric Acid Monohydrate (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59555-401-12 591 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2014 2 NDC:59555-401-11 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2014 3 NDC:59555-401-13 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333A 06/15/2014 Labeler - R&R Lotion, Inc. (062979000)