FDA.reportPublic FDA data

Dermovix

Manufacturer
Binger Consulting Corporation | Active Intelligence, LLC
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:39:40

Label at a glance#

ProductDermovix
Active ingredientALLANTOIN, PETROLATUM
Label structure10 sections

Indications and uses

• Scar Management • Temporarily protects minor cuts, scrapes and burns

Storage and handling

Other information store below 25°C (77° F), avoid direct sunlight

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 2.00%

Petrolatum 30.00%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If pregnant or breast feeding, contact physician prior to use.

Uses

INDICATIONS & USAGE SECTION

• Scar Management • Temporarily protects minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

• on deep or puncture wounds, animal bites, serious burns

• in large quantities, particularly over raw surfaces or blistered areas

When using this product

• avoid contact with eyes

Stop use and ask a doctor if

• condition worsens symptoms last more than 7 days or clear up and occur again within a few days

DOSAGE & ADMINISTRATION SECTION

Directions adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily

How to apply

• clean and dry affected area

• cut open pouch and remove patch

• remove protective film and apply directly to area

• apply to affected area not more than 3 times daily

• wash hands with soap after applying patch

• reseal pouch containing unused patches

INACTIVE INGREDIENT SECTION

Other ingredients lidocaine, vitamin E, onion extract

OTC - QUESTIONS SECTION

Questions or comments? call weekdays from 9 AM to 5 PM PST (888) 501-5651

STORAGE AND HANDLING SECTION

Other information store below 25°C (77° F), avoid direct sunlight

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermovixlbelDermovixlbel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1648752petrolatum 30 % Medicated PatchPSN4
1648752petrolatum 0.3 MG/MG Medicated PatchSCD4
1648752petrolatum 30 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69440-009-152021-10-21C16284748780-19d75b9d0-19cf-f424-e053-dadaa90a57ceDermovix
69440-009-152020-01-31C16284748780-19d75b9d0-19cf-f424-e053-dadaa90a57ceDermovix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69440-009-15Dermovix15 in 1 BOXPATCH154
69440-009-15Dermovix100 g in 1 PATCHPATCH1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69440-009DERMOVIX (ALLANTOIN,PETROLATUM) PATCH [BINGER CONSULTING CORPORATION]4Legacy NDC, 2 package rows20241129_33139e68-3714-41e8-a3a7-24f28e8b409b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69440-009-15EA - Each69440-009f2fd9e41-9496-445c-949b-3129d83f8b0e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z2
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
ALLANTOINACTIVE MOIETY344S277G0Z2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ12
LIDOCAINEINACTIVE INGREDIENT98PI2009872
ONIONINACTIVE INGREDIENT492225Q21H2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69440-00969440-009-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZACTIB
PETROLATUM4T6H12BN9UACTIB
LIDOCAINE98PI200987IACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ONION492225Q21HIACT

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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 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
997b5f51-5ea4-4d88-9462-7e403536555733139e68-3714-41e8-a3a7-24f28e8b409b2024-11-27WarningsExact identifier
spl id: 997b5f51-5ea4-4d88-9462-7e4035365557
spl set id: 33139e68-3714-41e8-a3a7-24f28e8b409b

Reported adverse events (FAERS/openFDA)#

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