Label: CELLSKIN CLEAN PINE- 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 April 3, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 70.00%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Glycerin, Butylene Glycol, 1,2-Hexanediol, Carbomer, Centella Asiatica Extract, Chamaecyparis Obtusa Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cymbopogon Nardus (Citronella) Oil, PEG-60 Hydrogenated Castor Oil, Triethanolamine

  • PURPOSE

    Purpose: SANITIZER

  • WARNINGS

    Warnings:

    1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.
    2. Do not use on wounded areas.
    3. Precautions for storage and handling
    a) Keep out of reach of children.
    b) Avoid direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Remove contaminants from the hands.

  • Directions

    Directions:

    1. Open the disposable pouch and put the entire amount of hand cleaner on your hand.

    2. Rub gently the front, back of your hands, between your fingers, and under your nails for 15 seconds.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CELLSKIN CLEAN PINE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71080-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1.05 g  in 1.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71080-0013-220 in 1 CARTON03/01/2020
    1NDC:71080-0013-11.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - GTG Wellness Co., Ltd. (689458057)
    Registrant - GTG Wellness Co., Ltd. (689458057)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyu Lnp Inc694752447manufacture(71080-0013)
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