Label: CELA NO-CLEAN HYPOCHLOROUS ACID DISINFECTANT- hypochlorous acid disinfectant liquid

  • NDC Code(s): 75318-0106-1, 75318-0106-2
  • Packager: Shanghai Wanlay Environmental Protection Technology Co., Ltd.
  • 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 December 23, 2020

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

  • Active Ingredient(s)

    Hypochlorous acid 111 mg/L. Purpose: Kill pyogenic coccus, intestinal pathogenic bacteria, pathogenic yeast, and common bacteria of hospital infection.

  • Purpose

    It is suitable for surgical hand antisepsis, hygienic hand antisepsis, skin disinfection (including damaged skin), disinfection of mucous membrane, general subject surface disinfection and air disinfection.

  • Use

    It is suitable for surgical hand antisepsis, hygienic hand antisepsis, skin disinfection (including damaged skin), disinfection of mucous membrane, general subject surface disinfection and air disinfection.

  • Warnings

    External Use Only.

    Keep out of reach children.

    ❶ Can’t mix with other product;

    ❷ Keep out of the sunlight, store in cool dry place, sealed preservation;

    ❸ Undrinkable water.

  • Do not use

    • on children less than 2 months of age
    • on open skin wounds
    • mixing this product with other disinfectants
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth.

    In case of contact with eyes, rinse eyes thoroughly with water.

    This product is for external use. It should not be taken orally.

    This product has a certain corrosive effect on metal objects other than stainless steel, and should be used with caution.

    When sterilizing articles containing more organic objects, they should be completely removed and then disinfected.

    Use with caution for those with sensitive skin.

    Do not mix this product with other disinfectants.

  • 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

  • Other information

    Storage: place it in a normal temperature and light-shielded environment.

  • Directions

    Content

    exposure time

    Methods
    hygienic hand antisepsis1minAfter washing hands, spray the product directly on both hands and rub
    surgical hand antisepsis3minWash and dry hands, forearms and lower upper arms with soap solution, then spray with appropriate amount of disinfectant and rub until dry
    disinfection of skin and mucous membranes3minSpray, repeatedly wipe or soak
    general subject surface disinfection3minspray, wipe or soak with the product directly
    air disinfection30minspray with the product directly in the air with the dosage of 10ml/m3

  • Inactive ingredients

    Sodium chloride, Water

  • Package Label - Principal Display Panel

    5L-C

  • INGREDIENTS AND APPEARANCE
    CELA NO-CLEAN HYPOCHLOROUS ACID DISINFECTANT 
    hypochlorous acid disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75318-0106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID555 mg  in 5 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75318-0106-24 in 1 BOX12/23/2020
    1NDC:75318-0106-15 L in 1 DRUM; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/23/2020
    Labeler - Shanghai Wanlay Environmental Protection Technology Co., Ltd. (416423042)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Wanlay Environmental Protection Technology Co., Ltd.416423042label(75318-0106) , manufacture(75318-0106)