PRESTO

Manufacturer
GADAL Laboratories, Inc
Effective date
2017-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:02:19

Label at a glance#

ProductPRESTO
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

 Active ingredient Purpose
Zinc Oxide 5.0 % Skin Protectant

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Purified Water, cyclotetrasiloxane , Isopropyl palmitate,
Ethylhexyl palmitate, Glycerin, Cyclopentasiloxane,
Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Dimethicone, Tocopherol
(Vitamin E), Zea Mays Oil, Retinyl palmitate(Vitamin A),
Cholecalciferol (Vitamin D), Beeswax, Hydrogenated Castor
Oil, Sodium Chloride, DMDM Hydantoin.

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.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Helps treat and prevent diaper rash.

WARNINGS

WARNINGS SECTION

For external use only. When using this product avoid contact with eyes. Stop use and ask a doctor if
• Condition worsens.
• Symptoms last more than 7 days or clear up and occur again within a few days.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Change wet and soiled diapers promptly. Cleanse the affected area, and allow to dry. Apply cream liberally as often as necessary, with each change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

PURPOSE

OTC - PURPOSE SECTION

• Helps treat and prevent diaper rash.
• Protects chafed skin associated with diaper rash and helps protect from wetness.

PRESTO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:
Drylock Technologies Ltd.
3921 North Hastings Way
Eau Claire, WI 54703
1-877-202-4652
questions@prestoabsorbent.com
© 2017 Drylock Technologies Ltd.
Made in USA with domestic and imported materials.

Label Image
Label Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53113-162-062021-01-29C16284748780-1ba0f9c33-400b-a910-e053-dadaa90a0b858e20513d-f257-4b2a-ab58-348bc9eddfe1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53113-162-06PRESTO177 mL in 1 BOTTLECREAM1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53113-162PRESTO (ZINC OXIDE) CREAM [GADAL LABORATORIES, INC]3Legacy NDC, 1 package rows20191226_8e20513d-f257-4b2a-ab58-348bc9eddfe1.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53113-16253113-162-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

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
f2f20142-6c20-4eed-86de-2f1d45a6a4e78e20513d-f257-4b2a-ab58-348bc9eddfe12017-12-15WarningsExact identifier
spl id: f2f20142-6c20-4eed-86de-2f1d45a6a4e7
spl set id: 8e20513d-f257-4b2a-ab58-348bc9eddfe1

Reported adverse events (FAERS/openFDA)#

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