FDA.reportPublic FDA data

Diabetic Itch Relief Cream

Manufacturer
Lavior Pharma Inc
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:51:33

Label at a glance#

ProductDiabetic Itch Relief Cream
Active ingredientOATMEAL
Label structure12 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema • poison ivy, oak, or sumac • insect bites

Dosage and administration

apply as needed

Storage and handling

Store at room temperature 20° – 25°C (68° – 77°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1%......................Skin Protectant

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to:

• rashes

• eczema

• poison ivy, oak, or sumac

• insect bites

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens

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

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 room temperature 20° – 25°C (68° – 77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Xanthan Gum, Glyceryl Stearate Citrate, Aloe Barbadensis Leaf Juice, Propanediol-1,3, Cetyl Alcohol, Sodium Benzoate, Potassium Sorbate, Biosaccharide Gum-1, Tocopheryl Acetate (Vitamin E), Sodium Gluconate, Citric Acid.

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diabetic Itch ReliefDiabetic Itch Relief

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71521-026-152026-01-29C16284748780-149896155-a117-586f-e063-e6dba90add90bdcfe9f9-60a6-be70-e053-2995a90aaa20
71521-026-502026-01-29C16284748780-149896155-a117-586f-e063-e6dba90add90bdcfe9f9-60a6-be70-e053-2995a90aaa20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71521-026DIABETIC ITCH RELIEF CREAM (COLLOIDAL OATMEAL) CREAM [LAVIOR PHARMA INC]9Legacy NDC20241024_bdcfe9f9-60a6-be70-e053-2995a90aaa20.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71521-02671521-026-50, 71521-026-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
DITTRICHIA VISCOSA WHOLE3SYW69FH88IACT
OATMEAL8PI54V663YACTIB
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CETYL ALCOHOL936JST6JCNIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
SODIUM GLUCONATER6Q3791S76IACT
PROPANEDIOL5965N8W85TIACT

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
4df3d10b-ac9d-cdb9-e063-6394a90ad322bdcfe9f9-60a6-be70-e053-2995a90aaa202026-03-26WarningsExact identifier
spl set id: bdcfe9f9-60a6-be70-e053-2995a90aaa20

Reported adverse events (FAERS/openFDA)#

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