FDA.reportPublic FDA data

Poxiezzz

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 22:48:12

Label at a glance#

ProductPoxiezzz
Active ingredientMENTHOL, UNSPECIFIED FORM, ZINC OXIDE
Label structure10 sections

Indications and uses

For the temporary relief of pain and itching associated with minor skin irritations Protects chafed skin

Dosage and administration

Not suitable for children under 2 years of age. Adults and children 2 years of age and older: Apply to affected area no more than 2 to 3 times daily. Shake well before use. Make sure the skin is clean and dry before spraying. Use a sweeping movement to spray-on the cream in a thin and uniform layer directly onto the affected skin. Use a spraying distance of approximately 2 to 3 inches. It is not necessary to rub t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1%

Zinc Oxide 4%

Purpose

DOSAGE & ADMINISTRATION SECTION

Topical Analgesic

Skin Protectant

Uses

OTC - PURPOSE SECTION

For the temporary relief of pain and itching associated with minor skin irritations

Protects chafed skin

Warning

WARNINGS SECTION

For external use only

When using this product

Avoid contact with eyes

Stop use and contact a Doctor if

OTC - STOP USE SECTION

Condition worsens .

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

Not to be applied over deep a 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

Not suitable for children under 2 years of age. Adults and children 2 years of age and older: Apply to affected area no more than 2 to 3 times daily. Shake well before use. Make sure the skin is clean and dry before spraying. Use a sweeping movement to spray-on the cream in a thin and uniform layer directly onto the affected skin. Use a spraying distance of approximately 2 to 3 inches. It is not necessary to rub the cream. When the skin is very sensitive, it is advised not to touch the skin too frequently.

Other information

INSTRUCTIONS FOR USE SECTION

Store at room temperature bellow 77º F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua)

Coco-Caprylate/Caprate

Glycerin

Cetearyl Alcohol

Cetearyl Glucoside

Alky-Alcohols

Alkyl Glucoside

Cocoglycerides

Caprylylglycol

Caprylhydroxamic Acid

Silica

Oleic Acid

Principle Display Panel.Bottle Spray 50 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PoxiezzzPoxiezzz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1733853menthol 1 % / zinc oxide 4 % Topical SprayPSN2
1733853menthol 10 MG/ML / zinc oxide 40 MG/ML Topical SpraySCD2
1733853menthol 1 % / zinc oxide 4 % Topical SpraySY2
1733853Menthol 10 MG/ML / ZNO 40 MG/ML Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70359-4106-12020-01-31C16284748780-19d75b9d0-18fd-f424-e053-dadaa90a57ce29e1bcc3-3356-591d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70359-4106-1Poxiezzz50 g in 1 BOTTLE, SPRAYSPRAY502
70359-4106-1Poxiezzz1 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70359-4106POXIEZZZ (MENTHOL, ZINC OXIDE) SPRAY [FORTUNIQUE B.V.]2Legacy NDC, 2 package rows20161217_29e1bcc3-3356-591d-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70359-410670359-4106-1

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
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
C12-20 ALKYL GLUCOSIDEK67N5Z1RUAIACT
COCO-GLYCERIDESISE9I7DNUGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OLEIC ACID2UMI9U37CPIACT
GLYCERINPDC6A3C0OXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
C14-22 ALCOHOLSB1K89384RJIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
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
43a40622-a711-2d7b-e054-00144ff8d46c29e1bcc3-3356-591d-e054-00144ff88e882016-12-14WarningsExact identifier
spl id: 43a40622-a711-2d7b-e054-00144ff8d46c
spl set id: 29e1bcc3-3356-591d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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