Label: HAND SANITIZING WIPES- benzalkonium chloride swab

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    61312-001-01, 61312-001-02, 61312-001-03, 61312-001-04, view more
    61312-001-05, 61312-001-06, 61312-001-07, 61312-001-08, 61312-001-09, 61312-001-10, 61312-001-11, 61312-001-12
  • Packager: HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.
  • 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 9, 2018

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

  • Active ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antibacterial

  • Use

    For hand sanitizing to decrease bacteria on the skin

    recommended for repeated use

  • Warnings

    For external use only.
    When useing this product avoid contact with eyes.In case of eye contact,flush eyes with water.
    Stop use and ask a doctor if irritation or redness develops.
    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children

    if swallowed

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

  • Directions

    Take wipe and rub thoroughly over all surfaces of both hands,Rub hands together briskly to dry .Dispose of wipe.

  • INACTIVE INGREDIENT

    Purified Water ,Glycerin,Aloe Barbadensis Leaf Juice,Anionic surfactant.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-001
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61312-001-0110 in 1 BOTTLE01/02/2018
    10.00468 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:61312-001-0225 in 1 BOTTLE01/02/2018
    20.00468 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:61312-001-0340 in 1 BOTTLE01/02/2018
    30.00468 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:61312-001-0460 in 1 BOTTLE01/02/2018
    40.00468 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:61312-001-05100 in 1 BOTTLE01/02/2018
    50.00468 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:61312-001-06120 in 1 BOTTLE01/02/2018
    60.00468 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:61312-001-07200 in 1 BOTTLE01/02/2018
    70.00468 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:61312-001-08240 in 1 BOTTLE01/02/2018
    80.00468 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:61312-001-09250 in 1 BOTTLE01/02/2018
    90.00468 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:61312-001-10800 in 1 BOTTLE01/02/2018
    100.00468 g in 1 POUCH; Type 0: Not a Combination Product
    11NDC:61312-001-111200 in 1 BOTTLE01/02/2018
    110.00468 g in 1 POUCH; Type 0: Not a Combination Product
    12NDC:61312-001-121500 in 1 BOTTLE01/02/2018
    120.00468 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/14/2013
    Labeler - HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD. (526890634)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU GUOGUANG TOURING COMMODITY CO., LTD.526890634manufacture(61312-001)