Label: HAND SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 81452-001-01, 81452-001-02, 81452-001-03, 81452-001-04 - Packager: CLEANHOME HOUSEHOLD
- This is a repackaged label.
- Source NDC Code(s): 81453-001
- 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 January 21, 2021
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- Active Ingredient
- Inactive ingredients
- Directions
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- Warning
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
benzalkonium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81452-001(NDC:81453-001) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SILVER CHLORIDE (UNII: MWB0804EO7) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81452-001-01 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2021 2 NDC:81452-001-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2021 3 NDC:81452-001-03 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2021 4 NDC:81452-001-04 20 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/22/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/21/2021 Labeler - CLEANHOME HOUSEHOLD (107152716) Registrant - CLEANHOME HOUSEHOLD (107152716) Establishment Name Address ID/FEI Business Operations JINHUA BANGCHEN PHARMACEUTICAL CO.,LTD 708321452 label(81452-001) , relabel(81452-001) , repack(81452-001) , pack(81452-001)
