Label: CELAVI HAND SANITIZING WET WIPES- 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 December 10, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.1%

  • INACTIVE INGREDIENTS

    Water, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Tocopheryl acetate, Citric acid

  • PURPOSE

    antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    ■instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

    ■instant hand antiseptic to decrease bacteria on the skin

  • WARNINGS

    Warnings

    For external use only


    When using this product
    ■ if following abnormal symptoms persist, discontinue use
    Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes
    ■ Stop immediately and consult a doctor if you experience
    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
    2) Skin Irritation
    3) Following Instructions when using medication
    (1) For external use only (Do not use internally)
    (2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
    ■ When used repeatedly in the same area, skin irritation may occur.
    ■Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.
    It is not recommended to use this one areas that have been medically treated with a cast or bandage.
    ■Do not use in combination with soap or antibacterial cleansing agents.

  • Directions

    ■ Scrub and wipe off the hand and skin, which are used individually or if necessary.

  • Other information

    ■ Read the directions and warnings before use

    ■ Avoid freezing and excessive heat above 40 ℃ (104 ℉)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    CELAVI HAND SANITIZING WET WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75770-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.16 g  in 162 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75770-010-01162 g in 1 CONTAINER; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - BLANC MER (695586548)
    Registrant - BLANC MER (695586548)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRSTCHAM CO., LTD689905446manufacture(75770-010)