Label: CHEMSTAR FOAMING HAND SANITIZER- benzalkonium chloride solution
- NDC Code(s): 63146-316-10
- Packager: Kay Chemical Company
- 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 November 14, 2022
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Principal Display Panel and Representative label
CHEMSTAR
Foaming
Hand Sanitizer
Sanitizante de manos en espuma
KEEP OUT OF REACH OF CHILDREN
FOR INSTITUTIONAL USE ONLY
Benzalkonium chloride 0.1%
Net Contents: 42 US fl oz (1250 ml)
1111302
Distributed by:
Kay Chemical Company
8300 Capital Drive • Greensboro, NC 27409
Made in USA • CSUSA 778273/8000/0621
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INGREDIENTS AND APPEARANCE
CHEMSTAR FOAMING HAND SANITIZER
benzalkonium chloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63146-316 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 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63146-316-10 1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/08/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 12/08/2010 Labeler - Kay Chemical Company (003237021)