FDA.reportPublic FDA data

ZIVA PERFUMED WIPES GARDENIA

Manufacturer
Ziva Wetwipes FZCo | Dirra USA
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:41

Label at a glance#

ProductZIVA PERFUMED WIPES GARDENIA
Active ingredientBENZETHONIUM CHLORIDE
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.1%

Direction for use

INDICATIONS & USAGE SECTION

Peel back the front label slowly. Pull wipes as needed. Reseal pouch by firmly running thumb over label to prevent moisture loss.

Precautions:

WARNINGS SECTION

For external use only. Do not apply to irritated or damaged skin. In case of gluteal erythema (redness of skin), contact your doctor or pharmacist. Keep in a cool place away from direct sunlight. Prevent contact with eyes. In case of irritation wash away with water immediately.

Other information

SPL UNCLASSIFIED SECTION

Store below 25°C 

Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Pentylene Glycol and Glyceryl Caprylate / Caprate, Perfume, PEG 40 Hydrogenated Castor Oil, Benzethonium Chloride, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2588058benzethonium chloride 0.1 % Medicated PadPSN4
2588058benzethonium chloride 1 MG/ML Medicated PadSCD4
2588058benzethonium chloride 0.1 % Medicated PadSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81450-007-012024-07-30C16284748780-1f386c649-b249-0266-e053-dadaa90a7c1aDrug Facts
81450-007-012023-06-03C16284748780-1f386c649-b249-0266-e053-dadaa90a7c1aDrug Facts
81450-007-012023-01-30C16284748780-1f386c649-b249-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81450-007-01ZIVA PERFUMED WIPES GARDENIA3.42 mL in 1 POUCHCLOTH3.424
81450-007-01ZIVA PERFUMED WIPES GARDENIA10 in 1 PACKAGECLOTH104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81450-007ZIVA PERFUMED WIPES GARDENIA (BENZETHONIUM CHLORIDE) CLOTH [ZIVA WETWIPES FZCO]4Legacy NDC, 2 package rows20231012_79f197ff-5440-47f4-9ace-69c0a143e47d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81450-00781450-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
GARDENIA JASMINOIDES FLOWER2TU49609L2IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
GLYCERYL CAPRYLATE/CAPRATEG7515SW10NIACT
PENTYLENE GLYCOL50C1307PZGIACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
06fdaec0-7c71-70cd-e063-6394a90a1b4679f197ff-5440-47f4-9ace-69c0a143e47d2023-10-05WarningsExact identifier
spl id: 06fdaec0-7c71-70cd-e063-6394a90a1b46
spl set id: 79f197ff-5440-47f4-9ace-69c0a143e47d

Reported adverse events (FAERS/openFDA)#

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