Label: DYNAREX HYDROGEL- glycerin gel

  • NDC Code(s): 67777-233-01, 67777-233-02
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 29, 2022

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

View All Sections
  • Active Ingredient

    Active Ingredient                  Purpose

    Glycerin 20.0%                    Skin Protectant

  • Purpose

    For dressing and management of stasis ulcers, pressure ulcers (stages I-IV) 1st and 2nd degree burns, cuts abrasions, skin irritations, post operative incisions, and skin conditions associated with peristomal care.

  • Warnings

    • If condition worsens or does not improve within 10-14 days, consult a physician.
    • Keep this and all medications out of the reach of children.
    • Follow directions for use.
  • Dosage & Administration Dynarex Hydrogel

    • Apply Wound Gel liberally to cover involved areas; apply as often as necessary.
    • If gauze is used as a wound covering, moisten first.
  • Keep out of reach of children

    • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN
  • Indications and Usage:

    Use:

    • For dressing and management of stasis ulcers,
    • pressure ulcers (stages I-IV)
    • 1st and 2nd degree burns,
    • cuts abrasions,
    • skin irritations,
    • post operative incisions,
    • and skin conditions associated with peristomal care.
  • Inactive Ingredient

    Inactive ingredients: Allantoin, Aloe Vera Gel, Diazolidinyl Urea, Methyparaben, PEG-4 Olivate, PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Propylparaben, Purified Water, Sodium Polyacrylate, Tetrasodium EDTA, Tocopherol Acetate.

  • PRINCIPAL DISPLAY PANEL

    1280 IN MASTER

  • INGREDIENTS AND APPEARANCE
    DYNAREX HYDROGEL 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-233
    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
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-233-0224 in 1 CASE05/26/2010
    1NDC:67777-233-0184.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/26/2010
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!