Label: BBTIME HAND SANITIZING WIPES- benzalkonium chloride cloth

  • 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 October 19, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • To decrease bacteria on the skin that could cause disease
    • Recommended for repeated use
  • WARNINGS

    Warnings: For external use only

    Flammable: Keep away from heat and flame

  • WHEN USING

    Keep out of eyes

    In case of contact with eyes, flush thoroughly with water

    Avoid contact with broken skin

    Do not inhale or ingest

  • STOP USE

    Stop use and ask a doctor

    • if irritation or redness develops
    • 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

  • DOSAGE & ADMINISTRATION

    • Wet hands thoroughly with product and allow to dry without wiping
    • Not recommended for infants
  • STORAGE AND HANDLING

    Other information

    • Do not store above 105°F
    • May discolor some fabrics harmful to wood finishes and plastics
  • INACTIVE INGREDIENT

    Aloe leaf juice 0.3%, water(aqua)

  • SPL UNCLASSIFIED SECTION

    DERMATOLOGIST TESTED

    PARABEN FREE

    SOOTHING ALOE VERA

    KILL 99.9% OF GERMS

    ALCOHOL FREE

    60 SOFT WIPES

    TO OPEN PACKAGE

    Flip open dispensing cap
    Locate wipe at center of rolland thread through small opening in lid
    For best results dispense wipes at angle
    When finished, snap lid acap shut to retain moisture

    For use at home, at work, ro on-the-go.

    DO NOT USE BEFORE AND AFTER EATING

    Feature & details:

    • Helps reduce the risk of infections

    • Leaves no stickiness or residue on hands

    • Removes light soils and dirt from hands

    Manufactured by Shandong Fengrui Biotechnology Co., Ltd.

    Manufactured in No.168, Qingwei Road, Dongliuting Community, Liuting sub-district, Qingdao, CHN

    DO NOT FLUSH

    NDC 80832-001-01

  • PRINCIPAL DISPLAY PANEL

    label of Benzalkonium Chloride sanitizing wipesNDC 80832-001-01

  • INGREDIENTS AND APPEARANCE
    BBTIME HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80832-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80832-001-017.8 g in 1 PACKAGE; Type 0: Not a Combination Product10/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/12/2020
    Labeler - Qingdao Fengrui Biotechnology Co., Ltd. (417156545)
    Registrant - Qingdao Fengrui Biotechnology Co., Ltd. (417156545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingdao Fengrui Biotechnology Co., Ltd.417156545label(80832-001) , manufacture(80832-001)
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