FDA.reportPublic FDA data

Diabetic Wound Gel Professional

Manufacturer
Lavior Inc
Effective date
2021-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:16

Label at a glance#

ProductDiabetic Wound Gel Professional
Active ingredientALLANTOIN
Label structure13 sections

Indications and uses

helps prevent and relieve dry, chafed, chapped, or cracked skin temporarily protects minor cuts, scrapes, and burns helps protect from the drying effects of wind and cold weather

Dosage and administration

apply a thin layer 1 to 2 times daily, or as directed by a doctor

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.5%.......................Skin Protectant

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and relieve dry, chafed, chapped, or cracked skin
  • temporarily protects minor cuts, scrapes, and burns
  • helps protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply a thin layer 1 to 2 times daily, or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Phenoxyethanol, Propanediol, Tocopheryl Acetate, Ethylhexylglycerin, Sodium Gluconate, Citric Acid, Sodium Hyaluronate

Questions?

OTC - QUESTIONS SECTION

Call toll free 1844-474-2552 or visit www.lavior.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diabetic Wound Gel ProDiabetic Wound Gel Pro

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045330allantoin 1 % Topical GelPSN1
1045330allantoin 0.01 MG/MG Topical GelSCD1
1045330allantoin 1 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71521-035-502023-01-30C16284748780-1f386c649-ffef-0266-e053-dadaa90a7c1ac1ed353e-3064-59c1-e053-2995a90ae0bd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71521-035-50Diabetic Wound Gel Professional50 g in 1 BOTTLE, PUMPGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-035DIABETIC WOUND GEL PROFESSIONAL (ALLANTOIN) GEL [LAVIOR INC]1Legacy NDC, 1 package rows20210510_c1ed353e-3064-59c1-e053-2995a90ae0bd.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71521-03571521-035-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYALURONATE SODIUMYSE9PPT4THIACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM GLUCONATER6Q3791S76IACT
DITTRICHIA VISCOSA WHOLE3SYW69FH88IACT

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c1ed32da-e568-b9f0-e053-2a95a90a1cbfc1ed353e-3064-59c1-e053-2995a90ae0bd2021-05-09WarningsExact identifier
spl id: c1ed32da-e568-b9f0-e053-2a95a90a1cbf
spl set id: c1ed353e-3064-59c1-e053-2995a90ae0bd

Reported adverse events (FAERS/openFDA)#

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