FDA.reportPublic FDA data

EM Shea Butter Cream

Manufacturer
Iruri Nature Handmade Soap & Cosmetic Inc
Effective date
2017-07-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:51:56

Label at a glance#

ProductEM Shea Butter Cream
Active ingredientSHEA BUTTER
Label structure8 sections

Indications and uses

Moisturizes skin.

Dosage and administration

After cleansing face, apply the adequate amount on skin.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Shea Butter (25.7%)

Purpose

OTC - PURPOSE SECTION

Skin protectant

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 (1-800-222-1222) right away.

Uses

INDICATIONS & USAGE SECTION

Moisturizes skin.

Warnings

WARNINGS SECTION

For external use only


Do not use when skin is red, inflamed, irritated, or painful


When using this product

- do not apply on other parts of the body
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Directions

DOSAGE & ADMINISTRATION SECTION

After cleansing face, apply the adequate amount on skin.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Coconut oil, Castor oil, Bees wax, Cocoa butter, Emulsifying wax, Distilled water, E.M, Lavender essential oil, Vitamin E oil, Optiphen plus

EM Shea Butter Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EM Shea Butter CreamEM Shea Butter Cream

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71547-102-022020-01-31C16284748780-19d75b9d0-5fcb-f424-e053-dadaa90a57ceEM Shea Butter Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71547-102-01EM Shea Butter Cream20 mL in 1 CONTAINERCREAM204
71547-102-02EM Shea Butter Cream1 in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71547-102EM SHEA BUTTER CREAM (SHEA BUTTER) CREAM [IRURI NATURE HANDMADE SOAP & COSMETIC INC]4Legacy NDC, 2 package rows20170714_54002ed4-7066-3d71-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71547-10271547-102-01, 71547-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
SHEA BUTTERK49155WL9YACTIB
YELLOW WAX2ZA36H0S2VIACT
COCOA BUTTER512OYT1CRRIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
COCONUT OILQ9L0O73W7LIACT
CASTOR OILD5340Y2I9GIACT
WATER059QF0KO0RIACT
LAVENDER OILZBP1YXW0H8IACT

Source Document#

Source XML · Source PDF

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
543b6f9c-35ee-19da-e054-00144ff8d46c54002ed4-7066-3d71-e054-00144ff8d46c2017-07-13WarningsExact identifier
spl id: 543b6f9c-35ee-19da-e054-00144ff8d46c
spl set id: 54002ed4-7066-3d71-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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