Label: HAND SANITIZER- benzalkonium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 81242-001-01, 81242-001-02 - Packager: Welch Materials (Zhejiang), 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 December 21, 2020
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- Directions
- Active Ingredient
- USE
- Warning
- Inactive ingredients
- 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:81242-001 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:81242-001-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2020 2 NDC:81242-001-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/21/2020 Labeler - Welch Materials (Zhejiang), Inc. (543257165) Registrant - Welch Materials (Zhejiang), Inc. (543257165) Establishment Name Address ID/FEI Business Operations Welch Materials (Zhejiang), Inc. 543257165 manufacture(81242-001) , label(81242-001)
100ml NDC 81242-001-02
