Active Ingredient
Glycerin 20%
Durma Dynagel
FDA Label NDC 67777-236
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Durma Dynagel (NDC 67777-236). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use(s), warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
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
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.
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 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?
• 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST.
Label
1280_in_master (1280 In Master R250130 5)
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