FDA.reportPublic FDA data

Promise Organics Diaper Cream

Manufacturer
Autumn Harp Incorporated | Autumn Harp Inc.
Effective date
2016-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:17:26

Label at a glance#

ProductPromise Organics Diaper Cream
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

• helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps protect skin from wetness

Dosage and administration

• change wet or soiled diapers promptly, cleanse the diaper area and allow to dry

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.00%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

• helps treat and prevent diaper rash

• protects chafed skin due to diaper rash and helps protect skin from wetness

Warnings

WARNINGS SECTION

For external use only

When using this product do not get into eyes

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

Directions

OTC - WHEN USING SECTION

• change wet or soiled diapers promptly, cleanse the diaper area and allow to dry

DOSAGE & ADMINISTRATION SECTION

• apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Beeswax*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Butyrospermum Parkii (Shea Butter)*, Colloidal Oatmeal*, Tocopherol (Vitamin E), Azadirachta indica (Neem) Kernel oil Organic*, Citric Acid.

* Certified Organic Ingredients

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelimage

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51514-0353-12020-07-17C16284748780-19d75b9d1-1164-f424-e053-dadaa90a57cePromise Organics Diaper Cream
51514-0353-12020-01-31C16284748780-19d75b9d1-1164-f424-e053-dadaa90a57cePromise Organics Diaper Cream

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51514-035351514-0353-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
SUNFLOWER OIL3W1JG795YIIACT
CASTOR OILD5340Y2I9GIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
OATMEAL8PI54V663YIACT
AZADIRACHTA INDICA BARKG580B439YIIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
SHEA BUTTERK49155WL9YIACT

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
298df384-7078-6a74-e063-6394a90aecb53d9385d0-6ef8-3d37-e054-00144ff88e882024-12-18WarningsExact identifier
spl set id: 3d9385d0-6ef8-3d37-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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