FDA.reportPublic FDA data

RevitaDERM Wound Care

Manufacturer
Blaine Labs Inc.
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:05:24

Label at a glance#

ProductRevitaDERM Wound Care
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

Uses     * 1st and 2nd Degree Burns     * Stasis Ulcers     * Pressure Ulcers     * Diabetic Ulcers     * Lacerations     * Abrasions     * Skin Tears     * Surgical Incision Sites     * Device Insertion Sites     * Graft Sites     * Donor Sites

Dosage and administration

Directions Evenly apply RevitaDERM Wound Care approximately 1/8 inch to 1/4 inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Benzalkonium Chloride (0.1%)

Purpose

OTC - PURPOSE SECTION

Purpose

Antimicrobial

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Uses

    * 1st and 2nd Degree Burns
    * Stasis Ulcers
    * Pressure Ulcers
    * Diabetic Ulcers
    * Lacerations
    * Abrasions
    * Skin Tears
    * Surgical Incision Sites
    * Device Insertion Sites
    * Graft Sites
    * Donor Sites

Warnings

WARNINGS SECTION

Warnings

For external use only.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use

RevitaDERM Wound Care Gel is for external use only. Avoid contact with eyes. If you get it in your eyes, rinse immediately with cool tap water. RevitaDERM Wound Care Gel may become discolored when it mixes with fluid from the wound. This is normal and not a cause for concern. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor. Talk with your doctor before you use any other medicines or cleansers on your skin. RevitaDERM Wound Care Gel does not contain sunscreen. Ask you doctor before you use RevitaDERM Wound Care Gel if you must be outside for a long period of time. If your symptoms do not get better or if they get worse, check with your doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Evenly apply RevitaDERM Wound Care approximately 1/8 inch to 1/4 inch thick to the wound area. Cover wound with appropriate dressing. Repeat as necessary to keep the wound moist.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis (Aloe) Leaf Juice, Aloe Barbadensis (Aloe) oil extract, Carbomer, Collagen, Elastin, Glycerin, Hyaluronic Acid, Triethanolamine, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blaine Labs

RevitaDERM WOUND CARE GEL

3 fl. oz. PHYSICIAN FORMULA

NDC: 63347-120-01

(800) 307-8818   Info@BlaineLabs.com    www.BlaineLabs.com    Blaine Labs, Inc.  Santa Fe Springs, CA 90670   Rev. 20120820

Blaine RevitaDERM1Blaine RevitaDERM1

Blaine RevitaDERM2Blaine RevitaDERM2

res

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN4
1310820RevitaDERM Wound Care 0.1 % Topical GelPSN4
1310820benzalkonium chloride 0.001 MG/MG Topical Gel [RevitaDERM Wound Care]SBD4
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD4
1049228benzalkonium chloride 0.1 % Topical GelSY4
1310820RevitaDERM Wound Care 0.001 MG/MG Topical GelSY4
1310820RevitaDERM Wound Care 0.1 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63347-120-012022-02-18C16284748780-1d6a99b39-8612-a426-e053-dadaa90af4c29254dada-4e32-43a0-892b-c488d68e23e7
63347-120-012022-01-28C16284748780-1d6a99b39-8612-a426-e053-dadaa90af4c29254dada-4e32-43a0-892b-c488d68e23e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-120-01RevitaDERM Wound Care89 mL in 1 TUBEGEL894

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-120REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE) GEL [BLAINE LABS INC.]4Current NDC, Legacy NDC, 1 package rows20231222_9254dada-4e32-43a0-892b-c488d68e23e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63347-120-01ML - Milliliter63347-12019e73614-c65a-4b43-818e-92123695d05412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO1
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY1
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WT1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1

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
63347-12063347-120-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)ZR28QKN0WTIACT
GLYCERINPDC6A3C0OXIACT
HYALURONIC ACIDS270N0TRQYIACT
TROLAMINE9O3K93S3TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTYLPARABEN3QPI1U3FV8IACT
ISOBUTYLPARABEN0QQJ25X58GIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ETHYLPARABENETHYLPARABEN14255EXE39GRANULE, FOR SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SUSPENSION / ORAL8 mgExact identifier — unii candidate
8 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+route
8 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SUSPENSION / ORAL8 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii+route
8 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii+route
8 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii+route
8 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39GRANULE, FOR SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii+route
8 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
8 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii+route
8 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ETHYLPARABENETHYLPARABEN14255EXE39SOLUTION / ORAL14 mgExact identifier — unii candidate
8 equally ranked IID candidates

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
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
ndc (package): 63347-120-01
ndc (product): 63347-120
ndc11 (package): 63347012001
spl id: 69b73949-a7e7-4e85-911e-ae688d658bbf
spl set id: 9254dada-4e32-43a0-892b-c488d68e23e7

Reported adverse events (FAERS/openFDA)#

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