FDA.reportPublic FDA data

SUDOCREM SKIN PROTECTANT CREAM

Manufacturer
LEDA INNOVATIONS USA, INC.
Effective date
2024-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:11

Label at a glance#

ProductSUDOCREM SKIN PROTECTANT
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps treat and prevent Diaper Rash and Incontinence Dermatitis Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness

Dosage and administration

Apply as needed For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide (15.29%)

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent Diaper Rash and Incontinence Dermatitis
  • Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply as needed
  • For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it 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.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature between 15C and 30C (59F to 86F)
  • Do not use if safety seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, water

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84589-002-10SUDOCREM SKIN PROTECTANT1 in 1 BLISTER PACKCREAM11
84589-002-10SUDOCREM SKIN PROTECTANT10 g in 1 JARCREAM101
84589-002-12SUDOCREM SKIN PROTECTANT125 g in 1 JARCREAM1251
84589-002-25SUDOCREM SKIN PROTECTANT250 g in 1 JARCREAM2501
84589-002-40SUDOCREM SKIN PROTECTANT400 g in 1 JARCREAM4001
84589-002-60SUDOCREM SKIN PROTECTANT60 g in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84589-002SUDOCREM SKIN PROTECTANT (ZINC OXIDE) CREAM [LEDA INNOVATIONS USA, INC.]1Current NDC, 6 package rows20240830_20d2cf0b-d237-fd78-e063-6394a90a8d03.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84589-00284589-002-10, 84589-002-60, 84589-002-12, 84589-002-25, 84589-002-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LANOLIN7EV65EAW6HIACT
LINALYL ACETATE5K47SSQ51GIACT
BENZYL CINNAMATEV67O3RO97UIACT
BENZYL BENZOATEN863NB338GIACT
SODIUM BENZOATEOJ245FE5EUIACT
ZINC OXIDESOI2LOH54ZACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
PARAFFINI9O0E3H2ZEIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
YELLOW WAX2ZA36H0S2VIACT
BENZYL ALCOHOLLKG8494WBHIACT
LAVENDER OILZBP1YXW0H8IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL ESTERS WAXD072FFP9GUIACT

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
SUDOCREM SKIN PROTECTANTZINC OXIDELEDA INNOVATIONS USA, INC.20d2cf0b-d237-fd78-e063-6394a90a8d032024-08-29WarningsExact identifier
ndc (package): 84589-002-10
ndc (package): 84589-002-40
ndc (package): 84589-002-12
ndc (package): 84589-002-60
ndc (package): 84589-002-25
ndc (product): 84589-002
ndc11 (package): 84589000225
ndc11 (package): 84589000212
ndc11 (package): 84589000260
ndc11 (package): 84589000240
ndc11 (package): 84589000210
spl id: 20d2cf0b-d236-fd78-e063-6394a90a8d03
spl set id: 20d2cf0b-d237-fd78-e063-6394a90a8d03

Reported adverse events (FAERS/openFDA)#

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