Label: CC USA NON-ALCOHOL FOAMING HAND SANITIZER- non-alcohol foaming hand sanitizer 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 September 17, 2020

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  • Acctive Ingredients

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Use(s)

    For hand washing to help reduce bacteria that cause disease. For use when soap and water are not available.

  • Inactive Ingredients:

    glycerin, decyl glucoside, purified water, aloe vera solution, citric acid.

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry. No rinsing required.

    Supervise children under 6 years of age when using this product.

  • Warnings

    For external use only

  • When using this product

    Do not get into eyes. If contact offurs, rinse thoroughly with water.

  • Stop use and ask a doctor

    if irritation and redness develop.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Package Label - Principal Display Panel

    999349 mL Tote LabelNDC: 75508-005-01 999349 mL

  • Package Label - Principal Display Panel

    208198 mL Drum LabelNDC: 75508-005-02 208198 mL

  • Package Label - Principal Display Panel

    3785.41 mL Gallon LabelNDC: 75508-005-03 3785.41 mL

  • Package Label - Principla Display Panel

    1892.7 mL half gallon labelNDC: 75508-005-04 1892.7 mL

  • Package Label - Principal Display Panel

    NDC: 75508-005-05 946.35 mL 946.35 mL 32 oz Label

  • Package Label - Principal Display Panel

    473.18 mL 16 oz LabelNDC: 75508-005-06 473.18 mL

  • Package Label - Principal Display Panel

    236.59 mL 8 oz LabelNDC: 75508-005-07 236.59 mL

  • Package Label - Principal Display Panel

    177.4 mL 6 oz LabelNDC: 75508-005-08 177.4 mL

  • Package Label - Principal Display Panel

    118.3 mL 4 oz LabelNDC: 75508-005-09 118.3 mL

  • Package Label - Principal Display Panel

    59.1 mL 2 oz LabelNDC: 75508-005-10 59.1 mL

  • INGREDIENTS AND APPEARANCE
    CC USA NON-ALCOHOL FOAMING HAND SANITIZER 
    non-alcohol foaming hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75508-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.005 mL  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.01 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 97.355 mL  in 100 mL
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75508-005-01999349 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/01/2020
    2NDC:75508-005-02208198 mL in 1 DRUM; Type 0: Not a Combination Product09/01/2020
    3NDC:75508-005-033785.41 mL in 1 JUG; Type 0: Not a Combination Product09/01/2020
    4NDC:75508-005-041892.7 mL in 1 JUG; Type 0: Not a Combination Product09/01/2020
    5NDC:75508-005-05946.35 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    6NDC:75508-005-06473.18 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    7NDC:75508-005-07236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    8NDC:75508-005-08177.4 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    9NDC:75508-005-09118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    10NDC:75508-005-1059.1 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/01/2020
    Labeler - Coil Chem LLC (963846535)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coil Chem LLC963846535manufacture(75508-005)
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