Label: BATHEAL HAND SANITIZING WIPES- hand sanitizing wipes 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 June 9, 2020

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

View All Sections
  • Active Ingredient(s)

    Benzalkonium Chloride 0.1%

  • Purpose

    Antibacterial

  • Use(s)

    Hand sanitizer to help reduce bacteria on the skin.

  • Warnings

    For External use only. For children under 3 years of age, consult with a doctor before use.

  • Do not use

    • on large areas of the body
    • if you are allergic to any of the ingredients
  • WHEN USING

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For adults and children of 3 years and over, wet hands thoroughly with product and allow to dry.
    • Supervise children under 6 years of age when using this product.
  • Other information

    • Store at room temperature
  • Inactive ingredients

    Water, Alcohol, Sodium Hydroxide, Fragnance

  • Package Label - Principal Display Panel

    NDC 75272-004-30

  • INGREDIENTS AND APPEARANCE
    BATHEAL HAND SANITIZING WIPES 
    hand sanitizing wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75272-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75272-004-30450 g in 1 PACKET; Type 0: Not a Combination Product06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - SUNJU CORPORATION (694816019)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHINE CO.,LTD688437450manufacture(75272-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!