SKYLARK ZINC OXIDE 20% DIAPER RASH CREAM

Manufacturer: SKYLARK CMC PRIVATE LIMITED
Effective date: 2017-09-11
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:52:28

Label at a glance#

ProductCMC ZINC OXIDE

Active ingredientZINC OXIDE

Label structure11 sections

Dosage and administration

for diaper rash change wet and soiled diapers promptly cleanse the diaper area and allow to dry apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged for poison ivy, oak, sumac apply ointment liberally as often as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (20% w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Purpose

INDICATIONS & USAGE SECTION

helps treat and prevent diaper rash
dries the oozing and weeping of poison ivy, poison oak, poison sumac

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes
do not use over large areas of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

if condition worsens
symptoms last more than 7 days or clear up and occur again within a few days
if you are allergic to any of these ingredients

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

Directions

DOSAGE & ADMINISTRATION SECTION

for diaper rash
change wet and soiled diapers promptly
cleanse the diaper area and allow to dry
apply ointment liberally with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
for poison ivy, oak, sumac
apply ointment liberally as often as needed

Other information

OTHER SAFETY INFORMATION

store at 56°-86° F (15-30°C)
avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft paraffin

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug factFront display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198911	zinc oxide 20 % Topical Ointment	PSN	1
198911	zinc oxide 0.2 MG/MG Topical Ointment	SCD	1
198911	zinc oxide 20 % Topical Ointment	SY	1
198911	zinc oxide 200 MG per GM Topical Ointment	SY	1
198911	ZNO 0.2 MG/MG Topical Ointment	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71168-3040-3	2020-01-31	C162847	48780-1	9d75b9d0-08f8-f424-e053-dadaa90a57ce	SKYLARK ZINC OXIDE 20% DIAPER RASH CREAM
71168-3040-4	2020-01-31	C162847	48780-1	9d75b9d0-08f8-f424-e053-dadaa90a57ce	SKYLARK ZINC OXIDE 20% DIAPER RASH CREAM
71168-3040-5	2020-01-31	C162847	48780-1	9d75b9d0-08f8-f424-e053-dadaa90a57ce	SKYLARK ZINC OXIDE 20% DIAPER RASH CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71168-3040-3	CMC ZINC OXIDE	28 g in 1 TUBE	OINTMENT	28	1
71168-3040-4	CMC ZINC OXIDE	56 g in 1 TUBE	OINTMENT	56	1
71168-3040-5	CMC ZINC OXIDE	425 g in 1 JAR	OINTMENT	425	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71168-3040	CMC ZINC OXIDE (ZINC OXIDE) OINTMENT [SKYLARK CMC PRIVATE LIMITED]	1	Legacy NDC, 3 package rows	20170912_58eec6dd-be0e-bafc-e053-2a91aa0a97cf.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

CMC ZINC OXIDE
ZINC OXIDE
CETETH-20
PETROLATUM
CETOSTEARYL ALCOHOL
LIGHT MINERAL OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71168-3040	71168-3040-3, 71168-3040-4, 71168-3040-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETETH-20	I835H2IHHX	IACT
PETROLATUM	4T6H12BN9U	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
LIGHT MINERAL OIL	N6K5787QVP	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
58eec6dd-be0f-bafc-e053-2a91aa0a97cf			58eec6dd-be0e-bafc-e053-2a91aa0a97cf	2017-09-11	Warnings	Exact identifier spl id: 58eec6dd-be0f-bafc-e053-2a91aa0a97cf spl set id: 58eec6dd-be0e-bafc-e053-2a91aa0a97cf

Reported adverse events (FAERS/openFDA)#

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