Label: ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth

  • NDC Code(s): 81614-015-20, 81614-015-50
  • Packager: Orange (Fujian) Sanitary Products 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 February 19, 2021

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  • Active Ingredient(s)

    BENZALKONIUM CHLORIDE 0.15% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Antibacterial Hand Wipes

  • Use

    USES:Single use wipes to cleanse hands and help prevent the spread of bacteria.

  • Warnings

    • For external use only.
    • Do not replace wipes used for medical procedures.
    • These wipes are meant for general cleansing.
    • Flammable. Keep away fire or sources of heat.
    • Avoid contact with eyes.
    • If eyes contact occurs, flush eyes with water.
    • Store at room temperature 59 ℉（15℃）-86 ℉（30℃）.
  • 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

    If irritation and redness develop. If condition continues, consult your health care practitoner.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • 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,ALOE EXTRACT,SODIUM PHENYLKALATE

  • Package Label - Principal Display Panel

    20 cloth NDC: 81614-015-20

    20 cloth label

    50 cloth NDC: 81614-015-50

    50 CLOTH LABEL

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81614-015
    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
    ALOE (UNII: V5VD430YW9)  
    SODIUM PHENYLLACTATE (UNII: KYI2U2BS89)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81614-015-2020 in 1 PACKAGE02/17/2021
    15.75 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:81614-015-5050 in 1 PACKAGE02/17/2021
    26 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/17/2021
    Labeler - Orange (Fujian) Sanitary Products Co., Ltd. (715236216)
    Registrant - Orange (Fujian) Sanitary Products Co., Ltd. (715236216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Orange (Fujian) Sanitary Products Co., Ltd.715236216manufacture(81614-015)
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