Label at a glance#

ProductAstonea EN SHIELD ALOE SOFT VITAMIN ENRICHED

Active ingredientZINC OXIDE

Label structure11 sections

Indications and uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Dosage and administration

■ 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 anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (3.8%w/w)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns 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

Stop Use and ask a doctor if

OTC - STOP USE SECTION

conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

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

■ 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 anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Other Information

SPL UNCLASSIFIED SECTION

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1089065	Zinc oxide (Topical)	zinc oxide 0.038 MG/MG Topical Ointment	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1089065	zinc oxide 3.8 % Topical Ointment	PSN	2
1089065	zinc oxide 0.038 MG/MG Topical Ointment	SCD	2
1089065	ZNO 0.038 MG/MG Topical Ointment	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
77338-306-64	2024-06-25	C162847	48780-1	1030e365-692e-111a-e063-dadaa90a10e2	Astonea Skin Enshield
77338-306-64	2024-01-30	C162847	48780-1	1030e365-692e-111a-e063-dadaa90a10e2	Astonea Skin Enshield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-306-64	AstoneaEN SHIELD ALOE SOFT VITAMIN ENRICHED	99.2 g in 1 TUBE	CREAM	99.2		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-306	ASTONEA EN SHIELD ALOE SOFT VITAMIN ENRICHED (ZINC OXIDE) CREAM [ASTONEA LABS PRIVATE LIMITED]	2	Legacy NDC, 1 package rows	20240627_ef7c1864-336d-c402-e053-2a95a90a8740.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Astonea EN SHIELD ALOE SOFT VITAMIN ENRICHED
ZINC OXIDE
WATER
SODIUM BENZOATE
CETETH-20
ALOE VERA LEAF
ALPHA-TOCOPHEROL
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
CHOLECALCIFEROL
GLYCERIN
LANOLIN
MINERAL OIL
PARAFFIN
MICROCRYSTALLINE WAX
PHENOXYETHANOL
PROPYLENE GLYCOL
FD&C YELLOW NO. 5
PONCEAU 4R
VITAMIN A PALMITATE
ETHYLHEXYLGLYCERIN
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-306	77338-306-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
CETETH-20	I835H2IHHX	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETYL ALCOHOL	936JST6JCN	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
PONCEAU 4R	Z525CBK9PG	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
1bbb5af1-74e6-0542-e063-6294a90a6520			ef7c1864-336d-c402-e053-2a95a90a8740	2024-06-25	Warnings	Exact identifier spl id: 1bbb5af1-74e6-0542-e063-6294a90a6520 spl set id: ef7c1864-336d-c402-e053-2a95a90a8740

Reported adverse events (FAERS/openFDA)#

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

Astonea