Drug labels

Desitin Maximum Strength Zinc Oxide Diaper Rash

ZINC OXIDE · Kenvue Brands LLC · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
1590101a-c968-fca5-e063-6394a90a7ccc
ID
2f357025-248d-8fe7-e063-6294a90ad14a
Effective time
20250228
Version
5
SPL product data elements

Desitin Maximum Strength Zinc Oxide Diaper Rash Zinc Oxide COD LIVER OIL LANOLIN PETROLATUM STARCH, CORN GLYCERIN SORBITAN SESQUIOLEATE YELLOW WAX .ALPHA.-TOCOPHEROL ACETATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) ZINC OXIDE ZINC OXIDE

SPL unclassified section
Drug Facts, Distributed by: Kenvue Brands LLC Summit, NJ 07901
Active ingredient
Active ingredient Zinc Oxide (40%)
Purpose
Purpose Skin Protectant
Indications and usage
Uses • helps treat and prevent diaper rash • protects chafed skin due to diaper rash and helps seal out wetness
Warnings

Warnings For external use only When using this product do not get into 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

When using
When using this product do not get into eyes
Stop use
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
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

Directions • change wet and soiled diapers promptly • cleanse the diaper area • allow to dry • apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Storage and handling
Other information • store at 20°C to 25°C (68°F to 77°F) • may stain clothing
Inactive ingredient

Inactive ingredients Petrolatum, Cod Liver Oil, Lanolin, Zea Mays (Corn) Starch, Glycerin, Beeswax, Sorbitan Sesquioleate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopheryl Acetate, Fragrance

Questions
Questions? Call toll-free 800-720-3843 or 215-273-8755 (collect)
Package label principal display panel

PRINCIPAL DISPLAY PANEL - 136 g Tube in a Carton Label #1 CHOICE OF PEDIATRICIANS & PARENTS Paraben-free Desitin ® Maximum Strength Paste 40% Zinc Oxide Diaper Rash Ointment Provides powerful, long-lasting relief NET WT 4.8 Oz (136 g) Desitin_1

Harmonized identifiers (openFDA)
Application number
M016
Brand name
Desitin Maximum Strength Zinc Oxide Diaper Rash
Generic name
ZINC OXIDE
Manufacturer name
Kenvue Brands LLC
Product NDC
69968-0848
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
ZINC OXIDE
RxCUI
1094560, 1797059
SPL ID
2f357025-248d-8fe7-e063-6294a90ad14a
SPL set ID
1590101a-c968-fca5-e063-6394a90a7ccc
Package NDC
69968-0848-9, 69968-0848-2, 69968-0848-4, 69968-0848-5, 69968-0848-1, 69968-0848-3
Is original packager
true
Upc
0312547034234
UNII
SOI2LOH54Z
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.