FDA.reportPublic FDA data

Premium Scar Patch

Manufacturer
Alivio Medical Products, LLC
Effective date
2015-04-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:20:41

Label at a glance#

ProductPremium Scar Patch
Active ingredientALLANTOIN, LIDOCAINE, PETROLATUM
Label structure9 sections

Storage and handling

Other Information : store below 25C (77F), avoid direct sunlight

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Active Ingredient

Allantoin 2.00 %

Lidocaine 4.00 %

Pterolatum 30.00 %

DESCRIPTION SECTION

Purpose

Allantoin 2.00 %  ........ Skin Protectant

Lidocaine 4.00 % ........ Topical Anesthetic

Petrolatum 30.00 %..... Skin Protectant

INDICATIONS & USAGE SECTION

Uses

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

-Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations

WARNINGS SECTION

Warnings

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

DESCRIPTION SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions:

How to apply - clean and dry affected area  -remove mesh from backing and apply to affected area

-use only one mesh at a time, and maximum of four mesh/day  -leave mesh on affected area for up to

8 hours  -do not use mesh for longer than 5 consecutive days  -children under 12 should consult

physician prior to use

STORAGE AND HANDLING SECTION

Other Information: store below 25C (77F), avoid direct sunlight

DESCRIPTION SECTION

Questions or comments? call weekdays from 9 AM to 5 PM CST 800-914-7435

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of labelcopy of label

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69512-020-012020-01-31C16284748780-19d75b9d0-4591-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69512-020-01Premium Scar Patch15 in 1 BOXPATCH153
69512-020-01Premium Scar Patch15 g in 1 PATCHPATCH153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69512-020PREMIUM SCAR PATCH (ALLANTOIN, LIDOCAINE, PETROLATUM) PATCH [ALIVIO MEDICAL PRODUCTS, LLC]32 package rows20150414_c3f3e86f-0def-4fd9-96dd-22931d78081c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69512-020-01EA - Each69512-02080a80920-5168-4259-ac9c-98cd63176c6d12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z3
LIDOCAINEACTIVE INGREDIENT98PI2009873
PETROLATUMACTIVE INGREDIENT4T6H12BN9U3
ALLANTOINACTIVE MOIETY344S277G0Z3
LIDOCAINEACTIVE MOIETY98PI2009873
PETROLATUMACTIVE MOIETY4T6H12BN9U3
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ13
ONIONINACTIVE INGREDIENT492225Q21H3

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
69512-02069512-020-01

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
LIDOCAINE98PI200987ACTIB
PETROLATUM4T6H12BN9UACTIB
.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.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact 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.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 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.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact 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.-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.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact 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
8ebdaa79-4eb9-4e26-8545-941e8032d713c3f3e86f-0def-4fd9-96dd-22931d78081c2015-04-13WarningsExact identifier
spl id: 8ebdaa79-4eb9-4e26-8545-941e8032d713
spl set id: c3f3e86f-0def-4fd9-96dd-22931d78081c

Reported adverse events (FAERS/openFDA)#

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