FDA.reportPublic FDA data

BALSHI MD Calming Hemp Seed Cream for Eczema Relief

Manufacturer
BALSHI MD DERMACEUTICALS
Effective date
2019-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:17:36

Label at a glance#

ProductBALSHI MD Calming Hemp Seed for Eczema Relief
Active ingredientOATMEAL
Label structure7 sections

Dosage and administration

Adults and children two-years of age or older: Apply as needed. Children under two-years of age: consult a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.00%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and ditching to due to Eczema or rashes.

WARNINGS:

WARNINGS SECTION

For external use only. Avoid contact with eyes.

If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children two-years of age or older: Apply as needed. Children under two-years of age: consult a physician.

ADDITIONAL INFORMATION:

SPL UNCLASSIFIED SECTION

for use on mild to moderate Eczema or as directed by physician. Store at room temperature.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, a-Bisabalol, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cannabis Sativa (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Emulsifying Wax NF, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Menthol, Phenoxyethanol, Potassium Sorbate, Xanthan Gum.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71070-96871070-968-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER4VBL71TY4YIACT
CHAMOMILEFGL3685T2XIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LICORICE61ZBX54883IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
MENTHOLL7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT
OATMEAL8PI54V663YACTIB

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
071ddf7f-16b3-10a9-e063-6394a90a6af438b9cd24-3305-48b2-9dd4-baf784102f0a2023-10-07WarningsExact identifier
spl set id: 38b9cd24-3305-48b2-9dd4-baf784102f0a

Reported adverse events (FAERS/openFDA)#

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