Label: ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel
- NDC Code(s): 74621-006-02
- Packager: Aogrand International Trade Corporation
- 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, 2023
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- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- DO NOT USE
- When using this product
- Stop use and ask a doctor
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Other information
- Package Label - Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74621-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) WATER (UNII: 059QF0KO0R) C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74621-006-02 480 g in 1 BOTTLE; Type 0: Not a Combination Product 05/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/23/2020 Labeler - Aogrand International Trade Corporation (421353092) Establishment Name Address ID/FEI Business Operations Aogrand International Trade Corporation 421353092 manufacture(74621-006)