SKYLARK

Manufacturer: Skylark CMC
Effective date: 2017-09-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:52:27

Label at a glance#

ProductSKYLARK

Active ingredientZINC OXIDE

Label structure10 sections

Indications and uses

Helps treat and prevent rash associated with diaper rash, incontinence or exposure to feces and urine Protects skin against irritation due to such rash and Helps protect skin from exposure to wetness

Dosage and administration

Change wet or soiled diapers promptly Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks, lower abdomen and inner thighs Allow area to dry Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 3.8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Helps treat and prevent rash associated with diaper rash, incontinence or exposure to feces and urine
Protects skin against irritation due to such rash and
Helps protect skin from exposure to wetness

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes
if eye contact occurs, flush with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or doesn't improve within seven 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 rightaway

Directions

DOSAGE & ADMINISTRATION SECTION

Change wet or soiled diapers promptly
Clean diaper area with a mild cleanser, paying special attention to the perineum, buttocks, lower abdomen and inner thighs
Allow area to dry
Apply to affected area as often as necessary or with each diaper change, especially at bedtime or anytime when exposure to soiled diapers may be prolonged

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance, Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopherol Acetate (Vitamin E), Water, White Petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front PanelDrug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1089065	zinc oxide 3.8 % Topical Ointment	PSN	1
1089065	zinc oxide 0.038 MG/MG Topical Ointment	SCD	1
1089065	ZNO 0.038 MG/MG Topical Ointment	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71168-8020-0	2020-01-31	C162847	48780-1	9d75b9d0-b8c0-f424-e053-dadaa90a57ce	58b2f3c7-a6c2-1bc4-e053-2a91aa0aba14
71168-8020-4	2020-01-31	C162847	48780-1	9d75b9d0-b8c0-f424-e053-dadaa90a57ce	58b2f3c7-a6c2-1bc4-e053-2a91aa0aba14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71168-8020-0	SKYLARK	100 g in 1 TUBE	OINTMENT	100		1
71168-8020-4	SKYLARK	452 g in 1 JAR	OINTMENT	452		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71168-8020	SKYLARK (ZINC OXIDE) OINTMENT [SKYLARK CMC]	1	Legacy NDC, 2 package rows	20170909_58b2f3c7-a6c2-1bc4-e053-2a91aa0aba14.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

SKYLARK
ZINC OXIDE
SODIUM BORATE
ALPHA-TOCOPHEROL
PETROLATUM
CHLOROXYLENOL
CHOLECALCIFEROL
CORN OIL
LANOLIN
MINERAL OIL
PARAFFIN
PHENOXYETHANOL
VITAMIN A PALMITATE
WATER
ALOE VERA LEAF

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71168-8020	71168-8020-0, 71168-8020-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM BORATE	91MBZ8H3QO	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
PETROLATUM	4T6H12BN9U	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
CHLOROXYLENOL	0F32U78V2Q	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
CORN OIL	8470G57WFM	IACT
LANOLIN	7EV65EAW6H	IACT
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
WATER	059QF0KO0R	IACT
ALOE VERA LEAF	ZY81Z83H0X	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
58b2f3c7-a6c3-1bc4-e053-2a91aa0aba14			58b2f3c7-a6c2-1bc4-e053-2a91aa0aba14	2017-09-08	Warnings	Exact identifier spl id: 58b2f3c7-a6c3-1bc4-e053-2a91aa0aba14 spl set id: 58b2f3c7-a6c2-1bc4-e053-2a91aa0aba14

Reported adverse events (FAERS/openFDA)#

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