Label: INSTANT SANITIZING WIPES- first safety instant sanitizing wipes cloth

  • 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 July 2, 2020

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  • Active Ingredient(s)

    Alcohol 75% v/v;

    Chlorohexidine Diacetate 0.1% v/v;

    Benzalkonium 0.1% v/v;

  • Purpose

    Antibacterial

  • Use

    • For hand washing to decrease bacteria on the skin.
    • Apply topically to the skin to help prevent cross contamination.
    • Recommended for repeated use.
    • Dries in seconds when used as directed.

  • Warnings

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

  • Do not use

    • on infants 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

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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

    Directions
    • To Open Package: Unscrew lid to remove.
    • Open foil bag.
    • Locate wipe in the center and insert corner of the wipe through opening in lid.
    • DO NOT PUSH FINGER THROUGH OPENING.
    • Replace lid.
    • Pull sheet up slightly to side. Always snap lid cap securely shut between uses to prevent moisture loss.

  • Other information

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

    Water, Chlorhexidine Diacetate, Benzalkonium Chloride, Nano Silver Ions, Vitamin E

  • Package Label - Principal Display Panel

    20 wipes in 1 bag. NDC: 78183-003-01;

    20pcs

    100 wipes in 1 bag. NDC: 78183-003-02;

    100

  • INGREDIENTS AND APPEARANCE
    INSTANT SANITIZING WIPES 
    first safety instant sanitizing wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78183-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 U  in 1 U
    Inactive Ingredients
    Ingredient NameStrength
    SILVER ACETATE (UNII: 19PPS85F9H) 0.00004 U  in 1 U
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) 0.001 U  in 1 U
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.001 U  in 1 U
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78183-003-0120 U in 1 BAG; Type 0: Not a Combination Product07/02/2020
    2NDC:78183-003-02100 U in 1 BAG; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Labeler - Kunming Ansheng Industry & Trade Co., Ltd. (421081801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kunming Ansheng Industry & Trade Co., Ltd.421081801label(78183-003) , manufacture(78183-003)
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