Label: DISINFECTION WIPES- ddac0.6% cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated June 10, 2020

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

  • SPL UNCLASSIFIED SECTION

    Disinfection wipes

  • Active Ingredient(s)

    DDAC 1g/pcs. Purpose: Antiseptic

  • Purpose

    Antiseptic, Disinfection wipes

  • Use

    Disinfection 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 to disinfect.
    • 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

    Purifiedwater
    Phenoxyethanol
    Ethyl hexyl glycerin
    Benzalkonium chloride
    Propylene glycol
    ALCOHOL
    Glycerin

  • Package Label - Principal Display Panel

    100

  • INGREDIENTS AND APPEARANCE
    DISINFECTION WIPES 
    ddac0.6% cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78572-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DMDM HYDANTOIN (UNII: BYR0546TOW) (DMDM HYDANTOIN - UNII:BYR0546TOW) DMDM HYDANTOIN1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78572-201-01100 in 1 BAG; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Qingyuan Branch Factory Of Guangzhou Sifeili Cleaning Products Co., Ltd. (554536314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Qingyuan Branch Factory Of Guangzhou Sifeili Cleaning Products Co., Ltd.554536314manufacture(78572-201)