DYNAREX HYDROGEL- glycerin gel 
Dynarex Corporation

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.

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1280 DynaGel Moisturizing Wound Hydrogel NDC 67777-233-01

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

Dosage & Administration Dynarex Hydrogel

Keep out of reach of children

Indications and Usage:

Use:

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.

1280 IN MASTER

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)

Revised: 11/2022
Document Id: ee9dca78-070e-46bc-e053-2a95a90aa56a
Set id: c92de291-2cab-429d-9ae1-a1e85d5d784e
Version: 18
Effective Time: 20221129
 
Dynarex Corporation