Label: DROXYD 3.98- chitosan liquid

  • Category: HUMAN OTC DRUG LABEL

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 28, 2023

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  • Active Ingredients

    Chitosan

  • Purpose

    Skin regeneration and Wrinkle relief

  • Use

    The skin's surface appears firmer and smoother with a more youthful look. Remodels the facial contours and reduces the thickness of subcutaneous fatty tissue helping to reduce the "double chin effect" providing you with a youthful complexion. Reinforces skin elasticity to provide plump and radiant complexion.

  • Directions

    [Preparation stage]

    After cleansing, use toner to clean up the skin.

    It must be used only after cleansing is complete, and especially pay attention to the cleanliness of your hands.

    If you use it after exfoliation, you can get more satisfactory results, and it is more effective if you give a simple massage before use.

    [Application stage]

    1. Prepare Core peptide(1st), Stable Chitin(2nd) and a syringe.

    2. Core Peptide(1st) only opens the plastic cap.

    3. A syringe inlet is injected into the center of the hole at the top of the Core Peptide(1st) to suction. (Total 3ml based on syringe).

    After the syringe is removed, the inlet is automatically sealed to prevent outside air from entering.

    4. Open the Stable Chitin(2nd) after referring to the precautions and inject the Core Peptide(1st).

    Due to the nature of the Stable Chitin component, it is not soluble in ampoule other than Core Peptide. (Not compatible)

    5. Close the vial opening of the Stable Chitin(2nd) with an elastomer tube and shake to dissolve the Stable Chitin.

    Check with eyes and if the Stable Chitin component does not appear in the form of a thread (slightly thick), apply it to the skin.

  • When Using

    Although it can be used immediately after melting, it is recommended to use after 12 hours after mixing the product and closing it with an elastomer tube after mixing the product to increase the activity and maximize the efficacy due to the nature of the formulation.

    After blending, only the elastomer tube is closed and stored at room temperature fresh out of direct sunlight.

    (Up to 21 days)

  • Ingredient

    Chitosan

  • Warnings

    For external use only.

    Keep away from heat.

  • Stop Using

    Stop use and ask a physician if skin irritation and redness occurs more that 72 hours.

  • Keep out of reach of children

    Keep out of reach of children, if swallowed, get medical help right away.

  • Package Label

    OXITICAL 80851-303

  • INGREDIENTS AND APPEARANCE
    DROXYD 3.98 
    chitosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80851-403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52) (CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) - UNII:5GV09YMO52) CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S)99.99 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.001 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80851-403-0120 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product11/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/12/2023
    Labeler - Oxytical (695504108)
    Registrant - Oxytical (695504108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Oxytical695504108manufacture(80851-403)