Label at a glance#

ProductSmarth PeriShield

Active ingredientZINC OXIDE

Label structure10 sections

Indications and uses

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

Dosage and administration

■ Change wet and 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 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 diaper rash,incontinence or exposure to feces and urine ■ Protects skin against irritation due to such rash an ■ 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Change wet and 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 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, Tocopheryl Acetate (Vitamin E) Water, White Petrolatum

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display

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	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
71486-8020-0	2020-01-31	C162847	48780-1	9d75b9d0-385c-f424-e053-dadaa90a57ce	Drug Facts
71486-8020-4	2020-01-31	C162847	48780-1	9d75b9d0-385c-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71486-8020-0	SmarthPeriShield	100 g in 1 TUBE	OINTMENT	100		1
71486-8020-4	SmarthPeriShield	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
71486-8020	SMARTH PERISHIELD (ZINC OXIDE) OINTMENT [GLINT COSMETICS PRIVATE LIMITED]	1	Legacy NDC, 2 package rows	20181121_7b20dedd-a991-486f-e053-2991aa0ab6ea.zip

Products#

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

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71486-8020	71486-8020-4, 71486-8020-0

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
ALOE VERA LEAF	ZY81Z83H0X	IACT
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
SODIUM BORATE	91MBZ8H3QO	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
WATER	059QF0KO0R	IACT
PETROLATUM	4T6H12BN9U	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
7b20dedd-a992-486f-e053-2991aa0ab6ea			7b20dedd-a991-486f-e053-2991aa0ab6ea	2018-11-20	Warnings	Exact identifier spl id: 7b20dedd-a992-486f-e053-2991aa0ab6ea spl set id: 7b20dedd-a991-486f-e053-2991aa0ab6ea

Reported adverse events (FAERS/openFDA)#

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

Smarth