FDA.reportPublic FDA data

Buttiezzz Intense

Manufacturer
Fortunique B.V.
Effective date
2016-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:48:11

Label at a glance#

ProductButtiezzz Intense
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps treat and prevent diaper rash Protect chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

Change wet or soiled diapers promptly Shake well before use. Make sure the thin is clean and dry before use. Use a sweeping movement to spray on the cream in a thin and uniform layer on the buttocks Buttiezzz Intense is more effective when you apply a single thin layer. Use a spraying distance approximately 2 to 3 inches. It is not necessary to rub the cream. Apply Butiezzz Intense liberally as often as necessary ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%

Purpose

DOSAGE & ADMINISTRATION SECTION

Skin Protectant

Uses

OTC - PURPOSE SECTION

Helps treat and prevent diaper rash

Protect chafed skin due to diaper rash and helps seal out wetness

Warning

WARNINGS SECTION

For external use only

Avoid contact with eyes

Stop use and contact a Doctor if

OTC - STOP USE SECTION

Condition worsens

Symptoms last more 7 days or clear up or occur within a few days

Not to be applied over deep or puncture wounds, infection or lacerations

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

INDICATIONS & USAGE SECTION

Change wet or soiled diapers promptly

Shake well before use. Make sure the thin is clean and dry before use. Use a sweeping movement to spray on the cream in a thin and uniform layer on the buttocks

Buttiezzz Intense is more effective when you apply a single thin layer. Use a spraying distance approximately 2 to 3 inches. It is not necessary to rub the cream. Apply Butiezzz Intense liberally as often as necessary or at every diaper change

Other Information

INSTRUCTIONS FOR USE SECTION

Store at room temperature bellow 77º F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water(aqua)

Coco-Caprilate/Caprate

Glycerin

Alkyl-Alcohols

Alkyl Glucoside

Propilene Glycol

Cocoglycerides

Caprylyl glycol

Capryl Hydroxamic acid

Chamomilla Recutita(Matricaria)Flower Extract

Calendula Officinalis Flower Extract

Silica

Oleic Acid

Principle Display Panel.50ml Bottle Spray carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Butiezzz Intense CartonButiezzz Intense Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1232104zinc oxide 10 % Topical SprayPSN2
1232104zinc oxide 100 MG/ML Topical SpraySCD2
1232104zinc oxide 10 % Topical SpraySY2
1232104ZNO 100 MG/ML Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70359-4102-12020-01-31C16284748780-19d75b9d0-f4c6-f424-e053-dadaa90a57ce29cfaabb-54c3-6fa2-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70359-4102-1Buttiezzz Intense1 in 1 CARTONSPRAY12
70359-4102-1Buttiezzz Intense50 g in 1 BOTTLE, SPRAYSPRAY502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70359-4102BUTTIEZZZ INTENSE (ZINC OXIDE) SPRAY [FORTUNIQUE B.V.]2Legacy NDC, 2 package rows20161215_29cfaabb-54c3-6fa2-e054-00144ff88e88.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70359-410270359-4102-1

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
NameUNIIKind
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COCO-GLYCERIDESISE9I7DNUGIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OLEIC ACID2UMI9U37CPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHAMOMILEFGL3685T2XIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
C14-22 ALCOHOLSB1K89384RJIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43a476ab-fac9-4302-e054-00144ff8d46c29cfaabb-54c3-6fa2-e054-00144ff88e882016-12-14WarningsExact identifier
spl id: 43a476ab-fac9-4302-e054-00144ff8d46c
spl set id: 29cfaabb-54c3-6fa2-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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