FDA.reportPublic FDA data

Palomar E Skin Rash

Manufacturer
PAL MIDWEST LTD.
Effective date
2018-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:52

Label at a glance#

ProductPalomar E Skin Rash
Active ingredientZinc Oxide
Label structure9 sections

Indications and uses

Provides prompt soothing relief for discomfort of skin irritations Helps restore skin to normal state Very beneficial at primary onset of chafing or any skin irritation

Dosage and administration

Apply as needed

Storage and handling

Smooth creamy formulation is easy to apply Wipes off with normal washing Does not stain clothing or bedding

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

  • Provides prompt soothing relief for discomfort of skin irritations
  • Helps restore skin to normal state
  • Very beneficial at primary onset of chafing or any skin irritation

WARNINGS

WARNINGS SECTION

  • For external use only

OTC - STOP USE SECTION

  • Stop use and ask doctor if
    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of children's reach

SPL UNCLASSIFIED SECTION

  • Do not get into eyes

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply as needed

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Smooth creamy formulation is easy to apply
  • Wipes off with normal washing
  • Does not stain clothing or bedding

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

(Alphabetically)

Anhydrous Lanolin, Beeswax, DL-Alpha Tocopheryl Acetate, Mineral Oil, Petrolatum, USP Boric Acid, Topical Starch

PRINCIPAL DISPLAY PANEL - 2 OZ. Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Palomar "E"

SOOTHING RELIEF

FOR MINOR
SKIN IRRITATIONS
SKIN RASH OINTMENT
WITH VITAMIN E

NET WT. – 2 OZ.

PRINCIPAL DISPLAY PANEL - 2 OZ. Jar Label
PRINCIPAL DISPLAY PANEL - 2 OZ. Jar Label

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
38142-500038142-5000-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
STARCH, CORNO8232NY3SJIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
BORIC ACIDR57ZHV85D4IACT

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
d607db8b-894d-433a-9d42-de8a3d13250fa613ec48-8865-4bd2-bcea-328c650314322021-09-22WarningsExact identifier
spl set id: a613ec48-8865-4bd2-bcea-328c65031432

Reported adverse events (FAERS/openFDA)#

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