Label: DISINFECTANT WIPES- wet wipes,antibacterial wipes 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 July 2, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient(s)

    BENZALKONIUM CHLORIDE,CETYLPYRIDINIUM CHLORIDE

  • Purpose

    Antibacterial

  • Use

    Open the cover whenusing, tear of the adhesive tape, can be exracteduse. use Afer, please fimely reduce the adhesive paste and close the cover to avoid inemal moisure eaporation.

  • Warnings

    1. This product is only for daily use and should be stored in a cool and sealed place.
    2. For extemal use only. If you find any skin discomfort or sensitivity, please stop using immediately.
    3. wipe the entryable items to be used after vlatilization;
    4. This product cannot be dissolved. Please do not throw it into the toilt.
    5. Iflammables, do not go near the source of fire.

  • 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

    • 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

    purified water USP,GLYCERIN,GLYCERIN,GLYCERIN

  • Package Label - Principal Display Panel

    1 CLOTH in 1 BAG NDC: 76641-001-01

    label

    10 CLOTH in 1 BAG NDC: 76641-001-02

    50 CLOTH in 1 BAG NDC: 76641-001-03

    100 CLOTH in 1 BAG NDC: 76641-001-01

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT WIPES 
    wet wipes,antibacterial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76641-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE2 mg  in 100 
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE1 mg  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76641-001-011 in 1 BAG; Type 0: Not a Combination Product05/20/2020
    2NDC:76641-001-0210 in 1 BAG; Type 0: Not a Combination Product05/20/2020
    3NDC:76641-001-0350 in 1 BAG; Type 0: Not a Combination Product05/20/2020
    4NDC:76641-001-04100 in 1 BAG; Type 0: Not a Combination Product05/20/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/20/2020
    Labeler - FuYang YangYang Health Technology Co. Ltd (529735460)
    Registrant - FuYang YangYang Health Technology Co. Ltd (529735460)
    Establishment
    NameAddressID/FEIBusiness Operations
    FuYang YangYang Health Technology Co. Ltd529735460manufacture(76641-001)