Label: ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER- benzalkonium chloride cloth
- NDC Code(s): 90119-001-02, 90119-001-40, 90119-001-80
- Packager: Orbizorb LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 26, 2023
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- Drug Facts
- Active ingredient
- Use
- Warnings
- Directions
- Inactive ingredients
- Package Labeling:
- Package Labeling:2wipes
- Package Labeling:40wipes
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INGREDIENTS AND APPEARANCE
ROUGH AND SMOOTH HEAVY DUTY ANTISEPTIC HAND SANITIZER
benzalkonium chloride clothProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:90119-001 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 WATER (UNII: 059QF0KO0R) POLOXALENE (UNII: V8B3K56SW0) PEG-75 LANOLIN (UNII: 09179OX7TB) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BRONOPOL (UNII: 6PU1E16C9W) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:90119-001-80 80 in 1 CANISTER 08/30/2020 1 612.48 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:90119-001-02 2 in 1 PACKAGE 09/20/2020 2 7.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:90119-001-40 40 in 1 PACKAGE 09/20/2020 3 7.656 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 08/30/2020 Labeler - Orbizorb LLC (117447551)