OTC - ACTIVE INGREDIENT SECTION
Active ingredient
White Petrolatum
ILEX Skin Protectant
- Manufacturer
- Denison Pharmaceuticals, LLC
- Effective date
- 2019-02-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:28:48
Label at a glance#
ProductILEX Skin Protectant
Active ingredientPETROLATUM
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Skin Protectant
INDICATIONS & USAGE SECTION
Uses
Prevention and treatment of skin irritations and excoriations caused by urinary and fecal material. Can be used on both intact and broken skin. Will adhere to moist weeping wounds. Suitable for adults, children and babies.
WARNINGS SECTION
Warnings
For external use only. Avoid contact with the eyes. Keep out of reach of children.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INACTIVE INGREDIENT SECTION
Inactive ingredients
Calcium / Sodium PVM / MA Copolymers, Corn Starch, Phenoxyethanol and Isopropyl Isobutyl Butylparabens, Sodium Carboxymethylcellulose, Zinc Oxide
DOSAGE & ADMINISTRATION SECTION
See directions for use
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- ILEX Skin Protectant
- Petrolatum
- STARCH, CORN
- BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)
- PHENOXYETHANOL
- ISOPROPYL ISOBUTYRATE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0295-4271 | 0295-4271-13, 0295-4271-01, 0295-4271-29 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | IACT |
| BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) | 389H2R62BD | IACT |
| PETROLATUM | 4T6H12BN9U | ACTIB |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| ISOPROPYL ISOBUTYRATE | IB2671N3UT | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | 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 |
|---|---|---|---|---|---|---|
| bc049b78-788b-43d5-e053-2a95a90a458a | 81b9e40a-cec3-4e2f-e053-2a91aa0a057a | 2021-02-23 | Warnings | 81b9e40a-cec3-4e2f-e053-2a91aa0a057a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.