Label: COSMERIT HAND SANITIZER 1G- alcohol gel

  • 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 4, 2020

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

  • ACTIVE INGREDIENT

    Alcohol

  • INACTIVE INGREDIENT

    Water, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Fragrance, Chlorphenesin, Trideceth-10, Butylene Glycol, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Vincetoxicum Atratum Extract, Scutellaria Baicalensis Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Illicium Verum (Anise) Fruit Extract

  • PURPOSE

    ■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease

    ■ instant hand antiseptic to decrease bacteria on the skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Pump an appropriate amount on to the hands and rub together until dry

  • WARNINGS

    1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the
    parts of body, or wounded skins (It may cause irritations)
    2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,
    itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.
    3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact
    occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin
    area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly
    inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product
    is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed
    gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina
    steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified.

  • DOSAGE & ADMINISTRATION

    external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    COSMERIT HAND SANITIZER 1G 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77049-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77049-0003-13785 mL in 1 CONTAINER; Type 0: Not a Combination Product07/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/04/2020
    Labeler - Interkos Co.,Ltd. (689850314)
    Registrant - Interkos Co.,Ltd. (689850314)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interkos Co.,Ltd.689850314manufacture(77049-0003)