Label: FOAMING HAND SANITIZER- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 0869-0492-21 - Packager: Vi-Jon
- 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 5, 2014
If you are a consumer or patient please visit this version.
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Claims
For questions, please visit www.mycleanpath.com or call (213) 568-0006. Manufactured by Vi-Jon, Inc. St. Louis MO 63114
To Dilute: Flip bottle, squeeze pod to fill measuring cup. Remove pump, add distilled water to fill line. Air bubble in cup is normal. CleanPath Refill pod only to be used with CleanPath Reusable Bottle. Do not use for any other purpose.
effctive at eliminating 99.9% of many common harmful germs in as little as 15 seconds
- Active ingredient
- Purpose
- Use
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- Directions
- Inactive ingredients
- Adverse reaction
- Principal display panel
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INGREDIENTS AND APPEARANCE
FOAMING HAND SANITIZER
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0492 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) DMDM HYDANTOIN (UNII: BYR0546TOW) CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP) ISOCETETH-20 (UNII: O020065R7Z) DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M) PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ) LAURETH-23 (UNII: N72LMW566G) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) FD&C RED NO. 40 (UNII: WZB9127XOA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0492-21 90 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/03/2014 Labeler - Vi-Jon (790752542) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(0869-0492)