Label: INSTANT HAND SANITIZER- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 69583-035-01 - Packager: Fun Zone, 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 September 5, 2020
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- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop using this product and consult a doctor If
- Keep out of reach of children
- Directions
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INSTANT HAND SANITIZER
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69583-035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.95 mg in 1 mL Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69583-035-01 35 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/04/2020 Labeler - Fun Zone, Inc. (803572929)