Label: 0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER- hand sanitizer gel

  • Category: HUMAN OTC DRUG LABEL

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 7, 2020

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    Keep out of reach of children

  • INDICATIONS & USAGE

    Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

    Indications & Usage Section

  • PURPOSE

    Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

    Purpose

  • DOSAGE & ADMINISTRATION

    Dosage form: Gel

    Directions: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

    Dosage

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13% v/v

    Active Ingredient

  • WARNINGS

    Warnings: For external use only. Flammable. Keep away from heat or flame.

    Warnings

    Do not use: In children less than 2 months of age. On open skin wounds.

    Do not use

    When using this product: Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    warnings_1

    Stop use and ask a doctor if: irritation or rash occurs. These may by signs o a serious condition.

    Stop use

  • INACTIVE INGREDIENT

    Aloe, glycerin, sterile distilled water

    Inactive Ingredients

  • PRINCIPAL DISPLAY PANEL

    Anti-Bacterial Hand Sanitizer (Disinfectant Gel) free - alcohol

    3.8L label NDC: 79635-019-05

    3.8L Label

  • PRINCIPAL DISPLAY PANEL

    60 ml label NDC:79635-019-01

    100 ml label NDC: 79635-019-02

    240 ml label NDC: 79635-019-03

    500 ml label NDC: 79635-019-04

    60/100/240/500 ml labels

  • INGREDIENTS AND APPEARANCE
    0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79635-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.14 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) 0.1 g  in 100 mL
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) 0.1 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.09 g  in 100 mL
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16) 0.5 g  in 100 mL
    WATER (UNII: 059QF0KO0R) 96.08 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79635-019-03240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    2NDC:79635-019-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    3NDC:79635-019-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    4NDC:79635-019-053800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    5NDC:79635-019-02100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/04/2020
    Labeler - BJ Goods LLC (117585173)
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