FDA.reportPublic FDA data

ZIVA BABY WIPES

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 BABY WIPES
Active ingredientZINC OXIDE
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 0.1%

Direction for use

INDICATIONS & USAGE SECTION

Peel back the front label or open  the flip top slowly. Pull wipes as needed. Gently cleanse your baby's skin using one or more wipes. Reseal pouch by firmly running thumb over label to close the flip top 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.

SPL UNCLASSIFIED SECTION

Store below 25°C

Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Zinc Oxide, Pentylene Glycol and Glyceryl Caprylate / Caprate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Propylene Glycol, Sodium cocoamphoacetate, Disodium cocoamphodiacetate,  Cocamidoproply Betaine, PEG 40 Hydrogenated Castor Oil, Chamomile Extract, PEG-120 Methyl Glucose Dioleate,  Disodium EDTA, Citric Acid.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2588075zinc oxide 0.1 % Medicated PadPSN4
2588075zinc oxide 1 MG/ML Medicated PadSCD4
2588075zinc oxide 0.1 % Medicated PadSY4
2588075ZNO 1 MG/ML Medicated PadSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81450-005-012024-07-30C16284748780-1f386c64a-3976-0266-e053-dadaa90a7c1aDrug Facts
81450-005-012023-06-03C16284748780-1f386c64a-3976-0266-e053-dadaa90a7c1aDrug Facts
81450-005-012023-01-30C16284748780-1f386c64a-3976-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81450-005-01ZIVA BABY WIPES4.59 mL in 1 POUCHCLOTH4.594
81450-005-01ZIVA BABY WIPES80 in 1 PACKAGECLOTH804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81450-005ZIVA BABY WIPES (ZINC OXIDE) CLOTH [ZIVA WETWIPES FZCO]4Legacy NDC, 2 package rows20231012_5ae9d3a9-bef4-45fb-ac71-7ee0be72856c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81450-00581450-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTYLENE GLYCOL50C1307PZGIACT
WATER059QF0KO0RIACT
GLYCERYL CAPRYLATE/CAPRATEG7515SW10NIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CHAMOMILEFGL3685T2XIACT
SODIUM COCOAMPHOACETATEW7Q5E87674IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
EDETATE DISODIUM7FLD91C86KIACT
ZINC OXIDESOI2LOH54ZACTIM

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
06fdbe50-9363-a608-e063-6394a90a40885ae9d3a9-bef4-45fb-ac71-7ee0be72856c2023-10-05WarningsExact identifier
spl id: 06fdbe50-9363-a608-e063-6394a90a4088
spl set id: 5ae9d3a9-bef4-45fb-ac71-7ee0be72856c

Reported adverse events (FAERS/openFDA)#

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