Galentic Hydrogel
FDA Label NDC 50382-013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Galentic Pharma (india) Private Limited for the product Galentic Hydrogel (NDC 50382-013). 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, warnings, dosage & administration dynarex hydrogel, keep out of reach of children, indications and usage:, inactive ingredient, principal display, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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 barbadensis 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

Principal Display

Galentic Hydrogel.jpg

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