Eczema and Psoriasis Therapy

Manufacturer: Sundial Group LLC
Effective date: 2013-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:04:43

Label at a glance#

ProductEczema and Psoriasis Therapy

Active ingredientFUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE

Label structure9 sections

Contacts and useful links#

PhoneLabel contact631-842-8800

Websitewww.sheamoisture.com

www.SheaMoisture.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients	Purpose
Fucus Vesiculosus Extract - (Tinc)	Remedy for eczema
Centella Asiatica Extract - (Tinc)	Reduces itching
Melissa Officinalis Extract - (Tinc)	Reduces irritation
Aloe Socotrina Extract - (1X)	Humectant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Warnings:For external use only.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Not to be used during pregnancy. Not to be used while nursing.

WARNINGS SECTION

Therapeutic use is not recommended in hyperthyroidism; long-term therapeutic use is not recommended. When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Lather in hands or on a washcloth and wash entire body. Rinse thoroughly. Gentle enough for the face and for daily use.

SPL UNCLASSIFIED SECTION

Other information: For use on mild to moderate eczema or psoriasis, or as directed by a physician.

INACTIVE INGREDIENT SECTION

Inactive ingredients: Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Palmitic Acid, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus, (Sunflower) Seed Oil (and) Salix Alba (Willow) Bark Extract, Saponified Butyrospermum Parkii (Shea) Butter, Saponified Cocos Nucifera, (Coconut) Oil, Saponified Elaeis Guineensis (Palm) Kernel Oil, Cocoa Pod Ash, Avena Sativa (Oat) Kernel Meal, Carbon, Avena Sativa (Oat) Kernel Flour, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Chloride, Tetrasodium EDTA, Tetrasodium Etidronate.

*Certified Organic Ingredient

OTC - QUESTIONS SECTION

Questions? 631-842-8800 or visit www.SheaMoisture.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Boxes

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58666-3122-6	2020-01-31	C162847	48780-1	9d75b9d0-1246-f424-e053-dadaa90a57ce	Eczema and Psoriasis Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58666-3122-6	Eczema and Psoriasis Therapy	141 g in 1 PACKAGE	SOAP	141		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58666-3122	ECZEMA AND PSORIASIS THERAPY (FUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE) SOAP [SUNDIAL GROUP LLC]	1	Legacy NDC, 1 package rows	20130710_662687ca-4ced-4434-ac48-b0b1dd6346d3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ALOE	ACTIVE INGREDIENT	V5VD430YW9	1
CENTELLA ASIATICA	ACTIVE INGREDIENT	7M867G6T1U	1
FUCUS VESICULOSUS	ACTIVE INGREDIENT	535G2ABX9M	1
MELISSA OFFICINALIS	ACTIVE INGREDIENT	YF70189L0N	1
ALOE	ACTIVE MOIETY	V5VD430YW9	1
CENTELLA ASIATICA	ACTIVE MOIETY	7M867G6T1U	1
FUCUS VESICULOSUS	ACTIVE MOIETY	535G2ABX9M	1
MELISSA OFFICINALIS	ACTIVE MOIETY	YF70189L0N	1
ACTIVATED CHARCOAL	INACTIVE INGREDIENT	2P3VWU3H10	1
COCOA	INACTIVE INGREDIENT	D9108TZ9KG	1
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
ETIDRONATE TETRASODIUM	INACTIVE INGREDIENT	CZZ9T1T1X4	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
OATMEAL	INACTIVE INGREDIENT	8PI54V663Y	1
PALM OIL	INACTIVE INGREDIENT	5QUO05548Z	1
PALMITIC ACID	INACTIVE INGREDIENT	2V16EO95H1	1
SALIX ALBA BARK	INACTIVE INGREDIENT	205MXS71H7	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
SODIUM PALM KERNELATE	INACTIVE INGREDIENT	6H91L1NXTW	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Eczema and Psoriasis Therapy
FUCUS VESICULOSUS, CENTELLA ASIATICA, MELISSA OFFICINALIS, ALOE
FUCUS VESICULOSUS
CENTELLA ASIATICA
MELISSA OFFICINALIS
ALOE
SODIUM PALM KERNELATE
WATER
GLYCERIN
PALMITIC ACID
SHEA BUTTER
SUNFLOWER OIL
SALIX ALBA BARK
COCONUT OIL
PALM OIL
COCOA
OATMEAL
ACTIVATED CHARCOAL
TEA TREE OIL
SODIUM CHLORIDE
EDETATE SODIUM
ETIDRONATE TETRASODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58666-3122	58666-3122-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FUCUS VESICULOSUS	535G2ABX9M	ACTIB
CENTELLA ASIATICA	7M867G6T1U	ACTIB
MELISSA OFFICINALIS	YF70189L0N	ACTIB
ALOE	V5VD430YW9	ACTIB
SODIUM PALM KERNELATE	6H91L1NXTW	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
PALMITIC ACID	2V16EO95H1	IACT
SHEA BUTTER	K49155WL9Y	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
SALIX ALBA BARK	205MXS71H7	IACT
COCONUT OIL	Q9L0O73W7L	IACT
PALM OIL	5QUO05548Z	IACT
COCOA	D9108TZ9KG	IACT
OATMEAL	8PI54V663Y	IACT
ACTIVATED CHARCOAL	2P3VWU3H10	IACT
TEA TREE OIL	VIF565UC2G	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
EDETATE SODIUM	MP1J8420LU	IACT
ETIDRONATE TETRASODIUM	CZZ9T1T1X4	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 232 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRATHECAL		131 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / ORAL		3822 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
PALMITIC ACID	PALMITIC ACID	2V16EO95H1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / TOPICAL	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAVENOUS		6320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAVENOUS	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVASCULAR	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL / TOPICAL	3 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	DROPS / OPHTHALMIC	0.08 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	TABLET / ORAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	INJECTION / INTRAMUSCULAR	0.01 %w/v		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SPONGE / TOPICAL	0.14 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAOCULAR		320 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	AEROSOL, FOAM / TOPICAL	23.6 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / OPHTHALMIC		55 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
COCONUT OIL	COCONUT OIL	Q9L0O73W7L	SOAP / TOPICAL	4.6 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
62adc9c2-9915-4de3-9713-2c13b1b6fecc			662687ca-4ced-4434-ac48-b0b1dd6346d3	2013-06-25	Warnings	Exact identifier spl id: 62adc9c2-9915-4de3-9713-2c13b1b6fecc spl set id: 662687ca-4ced-4434-ac48-b0b1dd6346d3

Reported adverse events (FAERS/openFDA)#

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