Label: APHOGEE SERIOUS CARE AND PROTECTION REFRESHING HAND SANITIZER- alcohol gel

  • 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 May 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 62% w/w (equivalent to or exceeds 67% V/V)

  • Purpose

    Antimicrobial

  • Uses

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For external use only.

    Flammable. Keep away from heat or flame.

    Stop use and consult a doctor if rash or irritation occur. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

  • Directions

    • dispense enough product to cover hands
    • rub hands together until dry
    • supervise children under 6 years of age when using to avoid swallowing
  • Other information

    • store between 15-30 C (59°-86°F)
    • avoid freezing and excessive heat above 40 C (104°F)
  • Inactive ingredients

    Water, Carbomer, Glycerin, Caprylic/Capric Triglyceride, Amino Methyl Propanol

  • Questions?

    Call 855-274-1313

  • SPL UNCLASSIFIED SECTION

    Distributed by
    KAB Brands
    Chatsworth,
    CA 91131

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    ApHogee®

    Serious Care & Protection

    Refreshing
    HAND
    SANITIZER

    • Quick and Effective
    • Enriched with Moisturizers
      for Softness
    • Formulated without Sulfates,
      Parabens or Pthalates

    KILLS 99.9% OF GERMS*

    2 FL OZ ℮ (59 mL)

    Principal Display Panel - 59 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    APHOGEE SERIOUS CARE AND PROTECTION REFRESHING HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54726-0000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54726-0000-159 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/01/2020
    Labeler - KAB Brands LLC. (840521277)
    Establishment
    NameAddressID/FEIBusiness Operations
    KDC/ONE Cosmetic Laboratories of America Inc.117449842MANUFACTURE(54726-0000)
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