FDA.reportPublic FDA data

Active Ingredients

Manufacturer
OL PHARMA TECH, LLC Drs PHARMACY
Effective date
2026-07-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-17 21:45:48

Label at a glance#

ProductDrs. DIAPER RASH MAXIMUM STRENGTH
Active ingredientZINC OXIDE, DIMETHICONE
Label structure11 sections

Indications and uses

helps treat and prevent diaper rash protects minor skin irritation due to diaper rash and helps seal out wetness

Dosage and administration

change wet and soiled diapers promptly cleanse the diaper area, and allow to dry apply cream 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

store between 20°C to 25 °C ( 68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 10%

Dimethicone 1 %

Stop using this product and ask a doctor

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects minor skin irritation due to diaper rash and helps seal out wetness

Warning

WARNINGS SECTION

  • For external use only
  • when using this product, do not get it into the eye

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • change wet and soiled diapers promptly
  • cleanse the diaper area, and allow to dry
  • apply cream 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 SECTION

store between 20°C to 25 °C ( 68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cod liver oil ( contains vitamin A & Vitamin D), propylene glycol, vitamin E, methylparaben, propylparaben, stearic acid, trolamine, ceteareth 20, cetostearyl alcohol, EDTA, mineral oil

purpose

OTC - PURPOSE SECTION

diaper rash cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

diaper rash maximum strengthdiaper rash maximum strength

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
80489-576-012026-01-29C16284748780-149896155-a4af-586f-e063-e6dba90add90161ba174-1b13-83cd-e063-6394a90af19c
80489-576-012026-01-29C16284748780-149896155-a4af-586f-e063-e6dba90add90161ba174-1b13-83cd-e063-6394a90af19c
80489-576-022026-01-29C16284748780-149896155-a4af-586f-e063-e6dba90add90161ba174-1b13-83cd-e063-6394a90af19c
80489-576-022026-01-29C16284748780-149896155-a4af-586f-e063-e6dba90add90161ba174-1b13-83cd-e063-6394a90af19c
80489-576-032026-01-29C16284748780-149896155-a4af-586f-e063-e6dba90add90161ba174-1b13-83cd-e063-6394a90af19c
80489-576-032026-01-29C16284748780-149896155-a4af-586f-e063-e6dba90add90161ba174-1b13-83cd-e063-6394a90af19c

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
80489-57680489-576-01, 80489-576-02, 80489-576-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
COD LIVER OILBBL281NWFGIACT
STEARIC ACID4ELV7Z65APIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ZINC OXIDESOI2LOH54ZACTIM
TROLAMINE9O3K93S3TKIACT
MINERAL OILT5L8T28FGPIACT
EDETATE DISODIUM7FLD91C86KIACT
DIMETHICONE92RU3N3Y1OACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-04-14full-release2026-06-01 00:11:04

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
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
ndc (package): 80489-576-02
ndc (package): 80489-576-01
ndc (package): 80489-576-03
ndc (product): 80489-576
ndc11 (package): 80489057602
ndc11 (package): 80489057601
ndc11 (package): 80489057603
spl id: 56368fba-54cb-5ca0-e063-6394a90a8abf
spl set id: 161ba174-1b13-83cd-e063-6394a90af19c

Reported adverse events (FAERS/openFDA)#

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