FDA.reportPublic FDA data

Proxivol

Manufacturer
Misemer Pharmaceutical
Effective date
2022-02-01
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:50:21

Label at a glance#

ProductProxivol
Label structure11 sections

Dosage and administration

Cleanse wound then apply Proxivol to the wound and skin surrounding the wound 3 - 4 times daily.

Storage and handling

Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Proxivol is a soothing wound gel that promotes a moist wound environment that is ideal for the healing process.

Directions:

SPL UNCLASSIFIED SECTION

Cleanse wound then apply Proxivol to the wound and skin surrounding the wound 3 - 4 times daily.

Indications:

INDICATIONS & USAGE SECTION

For the local management of painful skin wounds, including:
• Pressure ulcers
• Venus stasis ulcers
• Superficial wounds and scrapes
• 1st and 2nd degree burns

Warnings:

WARNINGS SECTION

External use only. Do not use this product if you are allergic to any of the ingredients. Avoid contact with eyes. Sterile unless opened or damaged.

Caution:

PRECAUTIONS SECTION

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Storage:

STORAGE AND HANDLING SECTION

Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

Ingredients:

SPL UNCLASSIFIED SECTION

Water, Lidocaine HCl, Collagen, Aloe Vera gel, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS:

SPL UNCLASSIFIED SECTION

Call your doctor about side effects. You may report side effects to Misemer Pharmaceutical at 1-662-993-9625 or the FDA at 1-800-FDA-1088.

How Supplied:

HOW SUPPLIED SECTION

Proxivol wound gel is supplied as a gel in:
1 oz. (28.33g) tube, NDC 0276-0603-28

SPL UNCLASSIFIED SECTION

Distributed By:
Misemer Pharmaceutical
Ripley, MS 38663

Item 0603

Rev 1021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0276-0603-28Proxivol28.33 g in 1 TUBE28.331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0276-0603PROXIVOL () [MISEMER PHARMACEUTICAL]11 package rows20220208_9d4635fd-34db-4375-8e08-9f0a4de66162.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0276-0603-28GM - Gram0276-0603bb432024-64a7-4f4c-9d59-d28f28c7deed12022-03-09

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0276-06030276-0603-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AIACT
BOVINE TYPE I COLLAGENFHJ3ATL51CIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM ALGINATEC269C4G2ZQIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
TROLAMINE9O3K93S3TKIACT
BENZETHONIUM CHLORIDEPH41D05744IACT

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 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58cbda7e-70c9-af85-e063-6394a90a0d172026-08-11WarningsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58b9b24c-7014-eb45-e063-6294a90ae4822026-08-10WarningsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsName fallback
generic name: WATER
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions)WATERBIOHERB Co., Ltd.16053e79-189e-4cdf-e063-6394a90ac7762026-04-11WarningsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsName fallback
generic name: WATER
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsName fallback
generic name: WATER
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsName fallback
generic name: WATER
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsName fallback
generic name: WATER
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsName fallback
generic name: WATER
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsName fallback
generic name: WATER
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsName fallback
generic name: WATER
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsName fallback
generic name: WATER

Reported adverse events (FAERS/openFDA)#

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