made of Diaper Rash Cream

Manufacturer: MADEOF, LLC
Effective date: 2020-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 23:03:07

Label at a glance#

Productmade of Diaper Rash Cream

Active ingredientZINC OXIDE

Label structure8 sections

Indications and uses

Helps prevent and treat diaper rash Protects chafed skin due to diaper rash Helps seal out wetness

Dosage and administration

Change wet or soiled diapers promptly Clean the diaper area Allow to dry Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

USP Zinc Oxide 14%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and treat diaper rash
Protects chafed skin due to diaper rash
Helps seal out wetness

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, symptoms last more than 7 days or clear up and return 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Change wet or soiled diapers promptly
Clean the diaper area
Allow to dry
Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Ingredients

INACTIVE INGREDIENT SECTION

¹Helianthus Annus* (Sunflower) Seed Oil, Cera Alba* (Beeswax), Cocos Nucifera* (Coconut) Oil, Olea Europaea' (Olive) Fruit Oil, Simmondsia Chinensis* (Jojoba) Oil, Butyrospermum Parkii* (Shea) Butter, Lavendula Angustilolia* (Lavender) Oil, Persea Grattisima*(Avocado) Oil, Argania Spinosa* (Argan) Oil, Tocopherol*

1 = Certified Organic

PRINCIPAL DISPLAY PANEL - 100.55 ml Box and Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

made of _®

Diaper Rash Cream

85% Certified Organic Ingredients

15% Natural

NSF
EWG VERIFIED
Non GMO

Nut Free

Soy Free

Dermatologist Tested

Pediatrician Tested

3.4 fl.oz (100.55ml)

Diaper Rash Tube

Diaper Rash box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1546589	zinc oxide 14 % Topical Cream	PSN	2
1546589	zinc oxide 140 MG/ML Topical Cream	SCD	2
1546589	zinc oxide 14 % Topical Cream	SY	2
1546589	ZNO 140 MG/ML Topical Cream	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71439-040-15	2023-01-30	C162847	48780-1	f386c649-ad7e-0266-e053-dadaa90a7c1a	made of ® Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71439-040-15	made of Diaper Rash Cream	1 in 1 CARTON	CREAM	1		2
71439-040-15	made of Diaper Rash Cream	100.55 mL in 1 TUBE	CREAM	100.55		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71439-040	MADE OF DIAPER RASH CREAM (ZINC OXIDE) CREAM [MADEOF, LLC]	2	Legacy NDC, 2 package rows	20200118_5876e61c-12d6-2313-e053-2a91aa0ab75a.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

made of Diaper Rash Cream
ZINC OXIDE
SUNFLOWER OIL
YELLOW WAX
TOCOPHEROL
LAVENDER OIL
SHEA BUTTER
AVOCADO OIL
ARGAN OIL
OLIVE OIL
COCONUT OIL
JOJOBA OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71439-040	71439-040-15

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
Name	UNII	Kind
SUNFLOWER OIL	3W1JG795YI	IACT
YELLOW WAX	2ZA36H0S2V	IACT
TOCOPHEROL	R0ZB2556P8	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
SHEA BUTTER	K49155WL9Y	IACT
AVOCADO OIL	6VNO72PFC1	IACT
ARGAN OIL	4V59G5UW9X	IACT
OLIVE OIL	6UYK2W1W1E	IACT
COCONUT OIL	Q9L0O73W7L	IACT
JOJOBA OIL	724GKU717M	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9c595e63-08c6-3358-e053-2995a90a54c4			5876e61c-12d6-2313-e053-2a91aa0ab75a	2020-01-17	Warnings	Exact identifier spl id: 9c595e63-08c6-3358-e053-2995a90a54c4 spl set id: 5876e61c-12d6-2313-e053-2a91aa0ab75a

Reported adverse events (FAERS/openFDA)#

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