Label: FENZ HAND SANITIZER 50 ML- 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 August 29, 2018

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  • Active Ingredients

    Benzalkonium Chloride..... 0.13%

  • Purpose

    Skin Antiseptic

  • Uses

    For hand and skin sanitizing to decrease microbes on skin.

  • Warnings

    For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.

  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

  • Keep out of reach of children

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

  • Directions

    Dispense an adequate amount in palm to cover hands. Rub hands together to cover skin thoroughly until dry. Supervise young children while using this product.

  • Other Information

    Skin cells may be shed naturally or by abrasion prior to 8 hours, exposing fresh, unprotected skin. Reapply as needed.

  • Inactive Ingredients

    Water, Calcium Silicate

  • Questions?

    inquiries@chcmindustries.com

    www.chcmindustries.com

    CHCM Industries

    3315 Williams Blvd Suite 2, #242

    Cedar Rapids, IA

  • Moisture-infused foam leaves skin silky

    • No Burn
    • No Cracking
    • No Drying
    • Alcohol Free
    • Provides up to 8 hours of protection*
    • Skin Loves It
    • Fragrance Free
    • Leaves Skin Soft
    • Won't Dry Skin
    • Kills 99.99% of germs
    • Shari'ah Compliant
    • Net Wt 50 mL

    Fenz-Hand-Display-Panel

  • INGREDIENTS AND APPEARANCE
    FENZ HAND SANITIZER  50 ML
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71315-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 99.83 g  in 100 mL
    CALCIUM SILICATE (UNII: S4255P4G5M) 0.04 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71315-120-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/20/2018
    2NDC:71315-120-02125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/29/2018
    3NDC:71315-120-03250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/29/2018
    4NDC:71315-120-041000 mL in 1 BAG; Type 0: Not a Combination Product08/29/2018
    5NDC:71315-120-053785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2018
    Labeler - CHCM Industries (081240688)
    Registrant - CHCM Industries (081240688)
    Establishment
    NameAddressID/FEIBusiness Operations
    MaxPax LLC017038858manufacture(71315-120)
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