THE ECZEMA
- Manufacturer
- Naples Soap Company
- Effective date
- 2023-01-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:41:27
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Fucus Vesiculosus (Tinc)
Hydrocotyle Asiatica (Tinc)
Aloe (3x)
Melissa Officinalis (3x)
OTC - PURPOSE SECTION
Fucus Vesiculosus - For eczema and psoriasis
Hydrocotyle Asiatica - For acne, rosacea, and itching
Aloe - Humectant
Melissa Officinalis - Reduces irritation; anti-bacterial/viral
INDICATIONS & USAGE SECTION
Uses: Reduce and relieve itching and irritation due to:
- eczema
- psoriasis
- chronic dry skin
WARNINGS SECTION
Warnings
For external use only.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If you are pregnant or breastfeeding, consult a physician first.
OTC - STOP USE SECTION
If problem worsens or symptoms of allergic reaction occur, discontinue use and contact a physician for further evaluation of condition.
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: Use with water to create lather and wash the body, then rinse thoroughly.
Use twice dally for optimum results. Safe for use on face, avoid contact with eyes
SPL UNCLASSIFIED SECTION
Other information: Naples Soap Company, 1200 5th Avenue South, Naples, FL 34102
INACTIVE INGREDIENT SECTION
Inactive ingredients: Sodium Palmate, Water/Aqua, Sodium Cocoate, Glycerin, Avena Sativa (Oat) Kernel Flour, Cocos Nucifera (Coconut) Oil, Sodium Citrate, Alcohol, Yogurt Extract, Sodium Chloride
OTC - QUESTIONS SECTION
Questions? 1-888-256-8265 or visit
www.naplessoap.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
THE ECZEMA SOAP
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69675-3273-7 | 2024-11-13 | C162847 | 48780-1 | 0191ceaa-711a-198a-e063-dbdaa90aec3e | THE ECZEMA SOAP |
| 69675-3273-7 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-711a-198a-e063-dbdaa90aec3e | THE ECZEMA SOAP |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| 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 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 1 | |
| COW MILK | INACTIVE INGREDIENT | 917J3173FT | 1 | |
| EDETATE SODIUM | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| OATMEAL | INACTIVE INGREDIENT | 8PI54V663Y | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SODIUM COCOATE | INACTIVE INGREDIENT | R1TQH25F4I | 1 | |
| SODIUM PALMATE | INACTIVE INGREDIENT | S0A6004K3Z | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- THE ECZEMA
- FUCUS VESICULOSUS, CENTELLA ASIATICA, ALOE, MELISSA OFFICINALIS
- ALCOHOL
- COW MILK
- WATER
- GLYCERIN
- SODIUM PALMATE
- SODIUM COCOATE
- OATMEAL
- COCONUT OIL
- SODIUM CHLORIDE
- EDETATE SODIUM
- SODIUM CITRATE
- FUCUS VESICULOSUS
- CENTELLA ASIATICA
- MELISSA OFFICINALIS
- ALOE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69675-3273 | 69675-3273-7 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| COW MILK | 917J3173FT | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM PALMATE | S0A6004K3Z | IACT |
| SODIUM COCOATE | R1TQH25F4I | IACT |
| OATMEAL | 8PI54V663Y | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| FUCUS VESICULOSUS | 535G2ABX9M | ACTIB |
| CENTELLA ASIATICA | 7M867G6T1U | ACTIB |
| MELISSA OFFICINALIS | YF70189L0N | ACTIB |
| ALOE | V5VD430YW9 | ACTIB |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | AEROSOL, FOAM / TOPICAL | 23.6 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAVITARY | 0.82 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | POWDER, FOR SUSPENSION / ORAL | 98 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRATHECAL | 9 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / SUBCUTANEOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRA-ARTICULAR | 26 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, COATED / ORAL | 54.7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / AURICULAR (OTIC) | 18 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SOAP / TOPICAL | 0.12 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | SHAMPOO / TOPICAL | 1.33 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PARENTERAL | 584 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRATHECAL | 131 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVITREAL | 10 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACAUDAL | 210 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAMUSCULAR | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL | 226 mg | ||
| EDETATE SODIUM | EDETATE SODIUM | MP1J8420LU | INJECTION / INTRAVENOUS | 0.01 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTERIAL | 278 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / NASAL | 330 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / RETROBULBAR | 648 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 0.86 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRACARDIAC | 70 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL | 1.35 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, CHEWABLE / ORAL | 20 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVENOUS | 90 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRADERMAL | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAMUSCULAR | 1486 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INFILTRATION | 648 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / OPHTHALMIC | 0.9 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / EPIDURAL | 0.9 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / OPHTHALMIC | 10 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 26bc68dd-1973-529d-e063-6394a90a92d7 | 153b54a7-4475-35bd-e054-00144ff88e88 | 2024-11-12 | Warnings | 153b54a7-4475-35bd-e054-00144ff88e88 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
