Label: CELLAPY DR SANITIZER- 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 March 20, 2020

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Ethanol (Synthetic Alcohol 70%)

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT:

    Glycerin, Propylene Glycol, Carbomer, Camellia Sinesis Leaf Extract, Aloe Barbadensis Leaf Extract, Sodium Hyaluronate, Triethanolamine, Citrus Limon (Lemon) Fruit Oil, Water

  • PURPOSE

    PURPOSE: Disinfecting Agent

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • Uses:

    Uses : Externally disinfects the hands and skin

  • WARNINGS

    Warnings
    For external use only
    When using this product if following abnormal symptoms persist, discontinue use
    1) Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes

    Stop immediately and consult a doctor if you experience
    1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
    2) Skin Irritation
    3) Following Instructions when using medication
    a) For external use only (Do not use internally)
    b) Avoid getting into the eyes
    (if contact occurs, wash well with clean water)
    Be careful to not inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.
    Do not use the product for a long time in the same area as swelling, inflammation may occur or sickness due to absorption through the skin.
    It is not recommended to use this one areas that have been medically treated with a cast or bandage.
    Do not use in combination with soap or antibacterial cleansing agents.
    Precautions
    1) Keep out of open flames
    2) Keep out of reach of children
    3) Do not replace the container with another as quality deterioration or accidents may occur

  • Directions

    Directions:
    Pour a small amount onto hands, spready evenly and rub into skin

  • PACKAGE LABEL - 70mL Tube

    Image of tube

  • PACKAGE LABEL - 500mL Bottle Pump

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    CELLAPY DR SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69278-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69278-110-0170 mL in 1 TUBE; Type 0: Not a Combination Product03/04/2020
    2NDC:69278-110-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/04/2020
    Labeler - GM Holdings Co., Ltd (688439958)
    Registrant - GM Holdings Co., Ltd (688439958)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Life Science Co.,ltd694914835manufacture(69278-110)