Label: FOAMING HAND SANITIZER WITH ALOE- benzalkonium chloride liquid

  • 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 July 14, 2010

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE  0.1% (ANTISEPTIC)

  • USES AND DIRECTIONS

    • USES: TO HELP REDUCE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.
    • DIRECTIONS: PUMP ENOUGH PRODUCT TO YOUR PALM TO THOROUGHLY COVER YOUR HANDS, RUB TOGETHER UNTIL DRY.
  • WARNINGS

    • FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT

    • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES WITH WATER.

    STOP USE AND ASK A DOCTOR IF

    • SKIN IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    • IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
  • PACKAGE FRONT AND BACK LABELS

    • 8OZ FRONT AND BACK LABELS: safeway8.jpg
      8OZ FRONT AND BACK LABELS
  • QUESTIONS/COMMENTS?

    1-888-723-3929

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER  WITH ALOE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1000 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-240-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/14/2010
    Labeler - SAFEWAY INC (009137209)
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