Label: SERA HAND-SANITIZING WIPE- 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 November 15, 2022

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

View All Sections
  • Active ingredients

    Benzalkonium chloride 0.1%

  • Purpose

    Antiseptic

  • Inactive ingredient

    Purified water, Glycerin, Hydroxyacetophenone, Cetylpyridinium chloride, Citric acid

  • Directions

    1. Open the cover, Pick as much as you needs, Wipe your body gently.

    2. Put sticker after using. There is risk of drying.

    3. Use it as soon as possible after opening.

    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    1. Store in cool and shady place, between 15-30C (59-86F)

    2. May discolor certain fabrics or surfaces.

  • Hand Sanitizer to hlep reduce bacteria

    Hypoallergenic.

    No harmful chemicals/

    Refreshness from no stickness, residue after using.

    Keep your hands clean when it's hard to wash your hands.

  • Stop use and ask a docotr if signs symptoms as follows:

    (1) signs of irritation and/or rash appears

    (2) signs of abnormality as above after exposed to sunlight.

  • Keep out of reach of children.

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

  • Avoid contact with eyes.

    In case of contact, rinse eyes thoroughly with water.

  • Do not dispose used tissue in the flushing toilet.

    Do not put used tissue into pack again.

    There is the risk of degeneration.

  • Warning

    Flammable. Keep away from heat or flame.

    Use only as intended and according to the directions of use.

  • Package Label

    42g NDC: 77748-201-01 Label

    280g NDC: 77748-201-02 Label

  • INGREDIENTS AND APPEARANCE
    SERA HAND-SANITIZING WIPE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77822-201
    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
    WATER (UNII: 059QF0KO0R)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77822-201-0142 g in 1 POUCH; Type 0: Not a Combination Product05/24/2020
    2NDC:77822-201-02280 g in 1 POUCH; Type 0: Not a Combination Product05/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/24/2020
    Labeler - SNG CO., LTD (694169027)
    Registrant - SNG CO., LTD (694169027)
    Establishment
    NameAddressID/FEIBusiness Operations
    SNG CO., LTD694169027manufacture(77822-201)
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!