FDA.reportPublic FDA data

Earth's Best Diaper Relief Ointment

Manufacturer
The Hain Celestial Group, Inc | The Hain Celestial Group, Inc.
Effective date
2021-02-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:50

Label at a glance#

ProductEarth Best Diaper Relief
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.0%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash.
  • Protects chafed skin associated with diaper rash.
  • Helps protect against wetness

WARNINGS SECTION

For external use only. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.

DOSAGE & ADMINISTRATION SECTION

Change wet diaper promptly. Clean diaper area and allow to dry. Apply generously with each diaper change and before bedtime.

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil * ,Beeswax*, Glyceryl Dibehenate, Tribehenin, Carthamus Tinctorius (Safflower) Oil* , Olea Europea (Olive) Fruit Oil *, Simmondsia Chinensis (Jojoba) Seed Oil*, Aloe Barbadensis Leaf Juice* , Calendula Officinalis Flower Extract* , Chamomilla Recutita (Matricaria) Flower Extract *, Glycerin *, Glyceryl Behenate, Tocopheryl Acetate.

* Certified Organic Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube labeltube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1727722zinc oxide 19 % Topical OintmentPSN3
1727722zinc oxide 19 MG/MG Topical OintmentSCD3
1727722zinc oxide 19 % Topical OintmentSY3
1727722zinc oxide 190 MG per GM Topical OintmentSY3
1727722ZNO 19 MG/MG Topical OintmentSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-4704-42023-01-30C16284748780-1ba0f9c33-4761-a910-e053-dadaa90a0b85Earth's Best Diaper Relief Ointment
61995-4704-42021-02-05C16284748780-1ba0f9c33-4761-a910-e053-dadaa90a0b85Earth's Best Diaper Relief Ointment
61995-4704-42021-01-29C16284748780-1ba0f9c33-4761-a910-e053-dadaa90a0b85Earth's Best Diaper Relief Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-4704-4Earth Best Diaper Relief113 g in 1 TUBEOINTMENT1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-4704EARTH BEST DIAPER RELIEF (ZINC OXIDE) OINTMENT [THE HAIN CELESTIAL GROUP, INC]3Legacy NDC, 1 package rows20210207_276f36c4-8f03-6eef-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-470461995-4704-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SAFFLOWER OIL65UEH262ISIACT
OLIVE OIL6UYK2W1W1EIACT
JOJOBA OIL724GKU717MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SUNFLOWER OIL3W1JG795YIIACT
TRIBEHENIN8OC9U7TQZ0IACT
YELLOW WAX2ZA36H0S2VIACT
ZINC OXIDESOI2LOH54ZACTIB

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
ba9fa82f-d6dc-782c-e053-2995a90a7317276f36c4-8f03-6eef-e054-00144ff88e882021-02-05WarningsExact identifier
spl id: ba9fa82f-d6dc-782c-e053-2995a90a7317
spl set id: 276f36c4-8f03-6eef-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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