Solox Gel

Manufacturer
Solus Rx, LLC
Effective date
2019-02-06
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:49:13

Label at a glance#

ProductSolox Gel
Label structure9 sections

Storage and handling

Store Solox Gel™ at room temperature (68 to 77°F (20 to 25°C)). Avoid storing in light. Although potency is unaffected by light exposure, Solox Gel™ can darken slightly with extensive exposure to light.

Label contents#

Full prescribing information#

PRODUCT DESCRIPTION

DESCRIPTION SECTION

Solox Gel™ is a clear amorphous prescription antimicrobial wound gel containing 55 ppm silver. Solox Gel™ is designed to provide a moist healing environment and to help control bioburden.

Solox Gel™ has been shown to inhibit the growth of: • Aspergillus niger and other fungi • Candida albicans • E. coli • MRSA • Pseudomonas aeruginosa • Staphylococcus aureus • Vancomycin-Resistant Enterococci (VRE)

INDICATIONS

INDICATIONS & USAGE SECTION

Exudate amounts: None, low or moderate. Do not use on wounds with highamount of exudate.
Solox Gel™ is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree bums, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.   

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Solox Gel™ is contraindicated to persons with allergies to any of the ingredients.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

There are no known side effects or adverse reactions.

INSTRUCTIONS

INSTRUCTIONS FOR USE SECTION

DIRECTIONS:
1. Cleanse wound.
2. Evenly apply Solox Gel™ approximately 1/8” to 1/4” thick to wound area.
3. If appropriate, cover wound with dressing as directed by a healthcare professional.
4. Repeat as necessary to keep the wound moist.

CHANGING THE DRESSING:
1. Remove secondary dressing, if one is applied.
2. Cleanse the wound bed to remove any remaining Solox Gel™.
3. Re-apply Solox Gel™, following the directions.

WARNING

WARNINGS SECTION

For external use only. If condition worsens or does not improve within 10-14 days, consult a physician. Keep this and all similar products out of the reach of children. In case of deep or puncture wounds, animal bites, or serious burns consult a physician.

STORAGE

STORAGE AND HANDLING SECTION

Store Solox Gel™ at room temperature (68 to 77°F (20 to 25°C)). Avoid storing in light. Although potency is unaffected by light exposure, Solox Gel™ can darken slightly with extensive exposure to light.

HOW SUPPLIED

HOW SUPPLIED SECTION

Solox Gel™ is supplied in a 1.5 oz. tube, NDC 72401-025-45. RX ONLY.

Made in the USA.

Distributed by: 

Solus Rx, LLC

D'Iberville, MS 39540

Solox Gel 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Solox Gel CartonSolox Gel Carton

Solox Gel TubeSolox Gel Tube

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72401-025-45Solox Gel45 mL in 1 TUBE451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72401-025SOLOX GEL () [SOLUS RX, LLC]11 package rows20190207_9d7471cb-019d-4862-bd18-34a2cafe74ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72401-025-45ML - Milliliter72401-025f1e61998-959b-4a86-8494-b6a63ded6b9612019-03-12

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72401-02572401-025-45

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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