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
SUDOCREM SKIN PROTECTANT CREAM
- Manufacturer
- LEDA INNOVATIONS USA, INC.
- Effective date
- 2024-08-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:57:06
Label at a glance#
ProductSUDOCREM SKIN PROTECTANT
Active ingredientZINC OXIDE
Label structure8 sections
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
Zinc Oxide (15%)
Purpose
Skin protectant
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
Warnings
For external use only.
When using this product
- do not get into eyes
Stop use and ask a doctor if
- conditions 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
Directions
- 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
- Store at room temperature between 15C and 30C (59F to 86F)
- Do not use if safety seal is broken or missing
Inactive ingredients
paraffin, paraffin wax, lanolin, microcrystalline wax, sorbitan sesquioleate, benzyl benzoate, beeswax, sodium benzoate, benzyl alcohol, propylene glycol, benzyl cinnamate, lavender oil, linalyl acetate, butylated hydroxyanisole, citric acid.
Product Packaging
Products#
Every source-derived product name is available through these pages.
- SUDOCREM SKIN PROTECTANT
- ZINC OXIDE
- LANOLIN
- LINALYL ACETATE
- BENZYL CINNAMATE
- BENZYL BENZOATE
- SODIUM BENZOATE
- MICROCRYSTALLINE WAX
- PARAFFIN
- PROPYLENE GLYCOL
- BUTYLATED HYDROXYANISOLE
- YELLOW WAX
- BENZYL ALCOHOL
- LAVENDER OIL
- SORBITAN SESQUIOLEATE
- CITRIC ACID MONOHYDRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84589-001 | 84589-001-10, 84589-001-60, 84589-001-12, 84589-001-25, 84589-001-40 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LANOLIN | 7EV65EAW6H | IACT |
| LINALYL ACETATE | 5K47SSQ51G | IACT |
| BENZYL CINNAMATE | V67O3RO97U | IACT |
| BENZYL BENZOATE | N863NB338G | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| LAVENDER OIL | ZBP1YXW0H8 | IACT |
| SORBITAN SESQUIOLEATE | 0W8RRI5W5A | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 20d31212-4426-85c4-e063-6394a90a19ff | 1f0a67cb-cbd1-2314-e063-6394a90a09e4 | 2024-08-29 | Warnings | 1f0a67cb-cbd1-2314-e063-6394a90a09e4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.