FDA.reportPublic FDA data

Diabetic Wound Gel

Manufacturer
Lavior Pharma Inc
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:51:23

Label at a glance#

ProductDiabetic Wound Gel
Active ingredientALLANTOIN
Label structure12 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 INGREDIENT SECTION

DB Wound LabelDB Wound Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DB Wound LabelDB Wound Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71521-036-152026-01-29C16284748780-149896155-bed7-586f-e063-e6dba90add90bdc55fbb-e391-0938-e053-2a95a90a1393
71521-036-502026-01-29C16284748780-149896155-bed7-586f-e063-e6dba90add90bdc55fbb-e391-0938-e053-2a95a90a1393

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-036DIABETIC WOUND GEL (ALLANTOIN) GEL [LAVIOR PHARMA INC]8Legacy NDC20241025_bdc55fbb-e391-0938-e053-2a95a90a1393.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
71521-03671521-036-50, 71521-036-15

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
4df3b76f-6163-b245-e063-6394a90aca55bdc55fbb-e391-0938-e053-2a95a90a13932026-03-26WarningsExact identifier
spl set id: bdc55fbb-e391-0938-e053-2a95a90a1393

Reported adverse events (FAERS/openFDA)#

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