FDA.reportPublic FDA data

Diabetic Skin Repair Cream

Manufacturer
Lavior Pharma Inc
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:51:27

Label at a glance#

ProductDiabetic Skin Repair Cream
Active ingredientDIMETHICONE
Label structure13 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Dosage and administration

Apply as needed.

Storage and handling

Store at 20° – 25°C (68° – 77°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%..............................Skin Protectant

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects chafed, chapped, or cracked skin.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Do not get into the eyes

Stop use and ask a physician if

OTC - STOP USE SECTION

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

Do not use on

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 as needed.

Other information

STORAGE AND HANDLING SECTION

Store at 20° – 25°C (68° – 77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Propanediol, Ricinus Communis (Castor) Seed Oil, Lauryl Laurate, Arachidyl Alcohol, Inula Viscosa Flower/Leaf/Stem Extract, Stearyl Alcohol, Behenyl Alcohol, Glycerin, Synthetic Beeswax, Arachidyl Glucoside, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Limonene, Sodium Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Potassium Sorbate, Disodium EDTA, Xanthan Gum, Hydrolyzed Vegetable Protein, Citrus Aurantium Dulcis (Orange) Peel Oil, Leuconostoc/Radish Root Ferment Filtrate, Linalool, Citral

Questions?

OTC - QUESTIONS SECTION

Call (305) 627-3680 or visit www.lavior.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DB Skin Repair LabelDB Skin Repair Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-397DIABETIC SKIN REPAIR CREAM (DIMETHICONE) CREAM [LAVIOR PHARMA INC]1Unmatched20241024_2514c852-77a0-688e-e063-6394a90aebb5.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71521-39771521-397-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
LIMONENE, (+)-GFD7C86Q1WIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
XANTHAN GUMTTV12P4NEEIACT
CARNAUBA WAXR12CBM0EIZIACT
EDETATE DISODIUM7FLD91C86KIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OACTIB
LAURYL LAURATEGPW77G0937IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
CASTOR OILD5340Y2I9GIACT
CITRALT7EU0O9VPPIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
GLYCERINPDC6A3C0OXIACT
DOCOSANOL9G1OE216XYIACT
LINALOOLD81QY6I88EIACT
DITTRICHIA VISCOSA WHOLE3SYW69FH88IACT
CANDELILLA WAXWL0328HX19IACT
ORANGE OILAKN3KSD11BIACT

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
4df3e90e-98a5-edbf-e063-6394a90ae3c92514c852-77a0-688e-e063-6394a90aebb52026-03-26WarningsExact identifier
spl set id: 2514c852-77a0-688e-e063-6394a90aebb5

Reported adverse events (FAERS/openFDA)#

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