Label: ANITISEPTIC SANITIZING WIPES- benzalkonium chloride cloth

  • Category: HUMAN OTC DRUG LABEL

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 September 20, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • USE

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

  • Warning

    For external use only
    Do not use
    ■Intheeyes.
    Stop use and ask doctor if:
    Irritation and 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.

  • Directions

    ■Wet hands thoroughly with product
    and allow to dry without wiping.

  • Inactive ingredients


    Aloe Vera, Benzoic Acid,
    Cocoamphodiacetate, Disodium, Glycerin,
    Tea Tree (Melaleuca Alternifolica) Leaf Oil,
    Menthol, Potassium Sorbate, Sodium
    Citrate, Water.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANITISEPTIC SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78601-002
    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
    MENTHOL (UNII: L7T10EIP3A)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78601-002-04180 in 1 BAG06/05/2020
    10.09477 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:78601-002-08180 in 1 PAIL06/05/2020
    20.09477 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:78601-002-09250 in 1 PAIL06/05/2020
    31.31625 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:78601-002-02900 in 1 BAG06/05/2020
    44.7385 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:78601-002-05250 in 1 BAG06/05/2020
    50.131625 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:78601-002-031200 in 1 BAG06/05/2020
    66.318 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:78601-002-0680 in 1 BAG06/05/2020
    70.04212 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:78601-002-07800 in 1 BAG06/05/2020
    80.4212 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:78601-002-1020 in 1 BAG06/05/2020
    90.01053 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:78601-002-0110 in 1 BAG06/05/2020
    100.005265 g in 1 POUCH; Type 0: Not a Combination Product
    11NDC:78601-002-11160 in 1 PAIL06/05/2020
    110.08424 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 finalpart333A06/05/2020
    Labeler - Jiaxing Qinya Sanitary Products Co., Ltd. (413135543)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiaxing Qinya Sanitary Products Co., Ltd.413135543manufacture(78601-002)