ACUTENS - KANJO - NATURAL ECZEMA RELIEF CREAM

Manufacturer
ACUTENS, INC.
Effective date
2023-09-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:18

Label at a glance#

ProductECZEMA RELIEF
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

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 1.00%

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

  • do not get into eyes.
  • to avoid slipping, use mat in tub or shower.
  • in some skin conditions, soaking too long may over dry.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help, or contact a Poison Control Center right away.

PREGNANCY SECTION

IF PREGNANT OR BREAST-FEEDING, ask a health professional before use

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Ceramide NG, Chamomilla Matricaria (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus
(Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

QUESTIONS?

OTC - QUESTIONS SECTION

(917) 745-3082

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_EczemaCreamLabel01b LBL_EczemaCreamLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN4
240651colloidal oatmeal 10 MG/ML Topical CreamSCD4
240651Avena sativa 1 % Topical CreamSY4
240651colloidal oatmeal 1 % Topical CreamSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80551-301-342025-01-30C16284748780-12cef2736-a73f-d83d-e063-dadaa90ab31fACUTENS - KANJO - NATURAL ECZEMA RELIEF CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80551-301-34ECZEMA RELIEF96 g in 1 TUBECREAM964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80551-301ECZEMA RELIEF (COLLOIDAL OATMEAL) CREAM [ACUTENS, INC.]4Legacy NDC, 1 package rows20230926_cd79a848-938a-18e2-e053-2a95a90a1a30.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80551-30180551-301-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
0632749f-b226-4d27-e063-6294a90a9ed7cd79a848-938a-18e2-e053-2a95a90a1a302023-09-25WarningsExact identifier
spl id: 0632749f-b226-4d27-e063-6294a90a9ed7
spl set id: cd79a848-938a-18e2-e053-2a95a90a1a30

Reported adverse events (FAERS/openFDA)#

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