Diaper Rash Cream 40% ZINC

Manufacturer: ASTONEA LABS PRIVATE LIMITED
Effective date: 2024-04-24
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:11:23

Label at a glance#

ProductDiaper Rash Cream 40% ZINC

Active ingredientZINC OXIDE

Label structure8 sections

Dosage and administration

change wet and soiled diapers promotly cleanse 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 will be prolonged

Storage and handling

store at 68º to 77ºF (20º to 25ºC) do not use if tube seal under cap is broken or missing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 40%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Warnings: For external use only.

When using this product

OTC - WHEN USING SECTION

When using this product do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symtoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not use if tube seal under cap is broken or missing

Directions

DOSAGE & ADMINISTRATION SECTION

change wet and soiled diapers promotly
cleanse 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 will be prolonged

Other information

STORAGE AND HANDLING SECTION

store at 68º to 77ºF (20º to 25ºC)
do not use if tube seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Petrolatum, Mineral Oil, Lanolin, Isopropyl Myristate, Beeswax, Tocopheryl Acetate, Cod Liver Oil, Aloe Barbadensis Leaf Juice

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1305337	zinc oxide 40 % Topical Cream	PSN	1
1305337	zinc oxide 400 MG/ML Topical Cream	SCD	1
1305337	zinc oxide 40 % Topical Cream	SY	1
1305337	ZNO 400 MG/ML Topical Cream	SY	1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77338-164-01	Diaper Rash Cream 40% ZINC	57 g in 1 TUBE	CREAM	57	1
77338-164-01	Diaper Rash Cream 40% ZINC	1 in 1 BOX	CREAM	1	1
77338-164-02	Diaper Rash Cream 40% ZINC	71 g in 1 TUBE	CREAM	71	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-164	DIAPER RASH CREAM 40% ZINC (ZINC OXIDE) CREAM [ASTONEA LABS PRIVATE LIMITED]	1	Current NDC, 3 package rows	20240426_16da985a-6210-ec82-e063-6294a90a132d.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Diaper Rash Cream 40% ZINC
Zinc Oxide
COD LIVER OIL
ISOPROPYL MYRISTATE
PETROLATUM
MINERAL OIL
LANOLIN
YELLOW WAX
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-164	77338-164-01, 77338-164-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COD LIVER OIL	BBL281NWFG	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
PETROLATUM	4T6H12BN9U	IACT
MINERAL OIL	T5L8T28FGP	IACT
LANOLIN	7EV65EAW6H	IACT
YELLOW WAX	2ZA36H0S2V	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB

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
Diaper Rash Cream 40% ZINC	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	16da985a-6210-ec82-e063-6294a90a132d	2024-04-24	Warnings	Exact identifier ndc (package): 77338-164-02 ndc (package): 77338-164-01 ndc (product): 77338-164 ndc11 (package): 77338016401 ndc11 (package): 77338016402 spl id: 16da8bcf-3e86-f435-e063-6294a90a7c8c spl set id: 16da985a-6210-ec82-e063-6294a90a132d

Reported adverse events (FAERS/openFDA)#

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