Label: ANTIBACTERIAL HAND 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 January 15, 2021

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

View All Sections
  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • USE

    For external use only .

    For hand washing to decrease bacteria on the skin.
    Recommended for repeated use.

  • Warning

    For external use only.

    Do not use
    If you are allergic to any of the ingredients. In the eyes; if contact occurs, rinse thoroughly with water.
    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

  • Directions

    Directions● Adults and children 2 yrs and over,
    apply to hands and allow skin to dry without wiping.
    ●Children under 2, ask doctor before use.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Cetylpyridinium Chloride, Chamomilla Recutita(Matricaria)Flower Extract, Citric Acid, Disodium Cocoamphodiacetate, Disodium EDTA, PEG-75 Lanolin,PEG-8Dimethicone,Phenoxyethanol,Potassium Sorbate, Quatermium-52, Sodium Benzoate, Water.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77720-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    QUATERNIUM-52 (UNII: 588EQF3H1P)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77720-019-011 in 1 BAG01/15/2021
    12.7 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:77720-019-0215 in 1 POUCH01/15/2021
    240.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:77720-019-0320 in 1 POUCH01/15/2021
    354 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:77720-019-0425 in 1 POUCH01/15/2021
    467.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    5NDC:77720-019-0530 in 1 POUCH01/15/2021
    581 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    6NDC:77720-019-0650 in 1 POUCH01/15/2021
    6135 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    7NDC:77720-019-0775 in 1 POUCH01/15/2021
    7202.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    8NDC:77720-019-08100 in 1 POUCH01/15/2021
    8270 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/15/2021
    Labeler - Skaffles Group Limited Liability Company (831115642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Da Xin Nonwoven Technology Co., Ltd.415363991manufacture(77720-019)
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!