MedPath

Durma DynaGel

1280 Durma DynaGel

Approved
Approval ID

3bcbe314-98ca-78f1-e063-6394a90a13ad

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 7, 2025

Manufacturers
FDA

Dynarex Corporation

DUNS: 008124539

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Durma DynaGel

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67777-236
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Durma DynaGel
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 7, 2025
FDA Product Classification

INGREDIENTS (12)

DIAZOLIDINYL UREAInactive
Code: H5RIZ3MPW4
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
GLYCERINActive
Quantity: 20 g in 100 g
Code: PDC6A3C0OX
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYOXYL 60 HYDROGENATED CASTOR OILInactive
Code: 02NG325BQG
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/21/2025

Label

1280_IN_MASTER1280 Durma DynaGel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/21/2025

Use(s)

• Temporarily protects and helps relieve minor skin irritation and itching of minor cute, scrapes, and burns

• Maintains a moist wound environment

• Ideal for management of stasis ulcers, pressure ulcers (stage 1-4), first second-degree burns, cuts, post-operative incicions, and skin conditions associated with peristomal care

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/21/2025

Active Ingredient

Glycerin 20%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/21/2025

Purpose

Skin Protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/21/2025

Warnings

For External Use Only

Do not use on

• deep or puncture wounds • Animal bites

When using this product

• Avoid contact with eyes.

Stop use and ask a doctor if

• Condition worsens or does not improve withing 10-14 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/21/2025

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.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/21/2025

Other Information

• Store at room temperature 15° - 30ºC (59° - 86°F) • Tamper evident. Do not use if seal is damaged.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/21/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/21/2025

Questions?

• 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 8/8/2025

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