Label: SANITARY WIPES- didecyl dimethyl ammonium chloride cloth

  • Contains inactivated NDC Code(s)
    NDC Code(s):     79467-201-01, 79467-201-02, 79467-201-03, 79467-201-04, view more
    79467-201-05, 79467-201-06, 79467-201-07, 79467-201-08, 79467-201-09, 79467-201-10, 79467-201-11, 79467-201-12, 79467-201-13, 79467-201-14, 79467-201-15, 79467-201-16, 79467-201-17, 79467-201-18, 79467-201-19, 79467-201-20, 79467-201-21, 79467-201-22, 79467-201-23, 79467-201-24, 79467-201-25, 79467-201-26, 79467-201-27, 79467-201-28, 79467-201-29, 79467-201-30, 79467-201-31, 79467-201-32, 79467-201-33
  • Packager: Shandong Qingran Biological Technology 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 November 30, 2020

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  • SPL UNCLASSIFIED SECTION

    Sanitary wipes

  • Active Ingredient(s)

    Didecyl dimethyl ammonium chloride 1.68ug/pcs.

    benzalkonium chloride 1.89ug/pcs.

    Purpose: Antiseptic

  • Purpose

    Antiseptic, Sanitary wipes

  • Use

    Sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    • Wipe the surface of the skin and let it dry naturally
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    WATER

  • Package Label - Principal Display Panel

    21

  • INGREDIENTS AND APPEARANCE
    SANITARY WIPES 
    didecyl dimethyl ammonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79467-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.89 ug
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE1.68 ug
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79467-201-0110 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    2NDC:79467-201-0220 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    3NDC:79467-201-0340 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    4NDC:79467-201-0450 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    5NDC:79467-201-0560 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    6NDC:79467-201-0680 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    7NDC:79467-201-07100 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    8NDC:79467-201-08160 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    9NDC:79467-201-09200 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    10NDC:79467-201-10400 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    11NDC:79467-201-111200 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    12NDC:79467-201-121 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    13NDC:79467-201-135 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    14NDC:79467-201-148 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    15NDC:79467-201-1518 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    16NDC:79467-201-1630 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    17NDC:79467-201-1740 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    18NDC:79467-201-1850 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    19NDC:79467-201-1960 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    20NDC:79467-201-2080 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    21NDC:79467-201-21100 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    22NDC:79467-201-22120 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    23NDC:79467-201-23150 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    24NDC:79467-201-24160 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    25NDC:79467-201-25200 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    26NDC:79467-201-26250 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    27NDC:79467-201-27300 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    28NDC:79467-201-28400 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    29NDC:79467-201-29500 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    30NDC:79467-201-30600 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    31NDC:79467-201-31800 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    32NDC:79467-201-321000 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    33NDC:79467-201-331100 in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Shandong Qingran Biological Technology Co., Ltd. (419744444)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Qingran Biological Technology Co., Ltd.419744444manufacture(79467-201)
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