Label: HYDRO GEL- glycerin 20% gel

  • NDC Code(s): 69396-127-03
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 19, 2024

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  • Drug Facts

  • Active Ingredient

    Glycerin 20%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching of minor cuts, scrapes and burns
    • Maintains a moist wound environment
    • Ideal for managment of stasis ulcers, pressure ulcers (stages 1-4), first and second degree burns, cuts, post-operative incisions, and skin conditions associated with peristomal care.
  • Stop use and ask a doctor

    • condition worsens or does not improve within 10-14 days
  • Keep out of the reach of children

    If swallowed get medical help or contact Poison Control Center right away

  • When Using this product

    Avoid contact with eyes

  • Directions

    • Apply liberally as often as necessary to cover affected areas.
    • If gauze is used as a wound covering, moisten first.
    • Children under 6 months: Consult a doctor before use
  • Warning

    For External Use Only

  • DO NOT USE

    Do not use on Deep pumcture wounds or Animal Bites

  • Other information

    Store at room temperature 15°-30°C (59°-86°F)

    **Tamper evident. Do not use if seal is damaged

  • Inactive Ingredients

    Allantoin, Aloe Vera gel, Diazolidinyl urea, Methylparaben, PEG-4 olivate, PEG-60, hydrogenated castor oil, Propylene glycol, Propylparaben, Purified water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol acetate

  • Questions or Comments

    Call Toll Free 1-888-296-9067

  • Distributed By

    Distributed By

    Trifecta Pharmaceuticals USA®

    101 NE Third Avenue Suite 1500

    Fort Lauderdale, FL. 33301 USA

    www.trifecta-pharma.com

  • PRINCIPAL DISPLAY PANEL

    4852 GLOBE HYDROGEL 3OZ 062523 CDER

  • INGREDIENTS AND APPEARANCE
    HYDRO GEL 
    glycerin 20% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-4 OLEATE (UNII: 9QL37EC4J7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-127-031 in 1 BOX08/23/2023
    184.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/14/2023
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
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