Active Ingredient
Glycerin 20%
Hydro Gel
FDA Label NDC 69396-127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa Llc for the product Hydro Gel (NDC 69396-127). 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, uses, stop use and ask a doctor, keep out of the reach of children, when using this product, directions, warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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