Hydro Gel

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:36

Label at a glance#

ProductHydro Gel
Active ingredientGLYCERIN
Label structure14 sections

Indications and 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.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 20%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • 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

OTC - STOP USE SECTION

  • condition worsens or does not improve within 10-14 days

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact Poison Control Center right away

When Using this product

OTC - WHEN USING SECTION

Avoid contact with eyes

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

WARNINGS SECTION

For External Use Only

DO NOT USE

OTC - DO NOT USE SECTION

Do not use on Deep pumcture wounds or Animal Bites

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 15°-30°C (59°-86°F)

**Tamper evident. Do not use if seal is damaged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Call Toll Free 1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

Distributed By

Trifecta Pharmaceuticals USA®

101 NE Third Avenue Suite 1500

Fort Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4852 GLOBE HYDROGEL 3OZ 062523 CDER4852 GLOBE HYDROGEL 3OZ 062523 CDER

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-127-03Hydro Gel1 in 1 BOXGEL12
69396-127-03Hydro Gel84.7 g in 1 TUBEGEL84.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-127HYDRO GEL (GLYCERIN 20%) GEL [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20240120_02e8e5d0-7844-39fe-e063-6394a90a57e1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-12769396-127-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
ndc (package): 69396-127-03
ndc (product): 69396-127
ndc11 (package): 69396012703
spl id: 0f4e25fa-bccd-b725-e063-6294a90ac340
spl set id: 02e8e5d0-7844-39fe-e063-6394a90a57e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.