Skin Protectant Cream 43% Petrolatum

Manufacturer
Swiss-American CDMO, LLC
Effective date
2023-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:21:25

Label at a glance#

ProductSkin Protectant Cream 43% Petrolatum
Active ingredientPETROLATUM
Label structure6 sections

Indications and uses

For the temporary protection of: diaper rash, minor: cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin. Helps protect from drying effects of wind and cold weather.

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes. Stop use and ask physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Do not use on deep or puncture wounds, animal bites or serious burns.

Uses

INDICATIONS & USAGE SECTION

For the temporary protection of: diaper rash, minor: cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin. Helps protect from drying effects of wind and cold weather.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 43%   Skin Protectant

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Hydroxylated Lanolin, PEG-30 Dipolyhydroxystearate, Sorbitan Sesquioleate, Mineral Oil, Glycerin, Steareth-20, Ozokerite Wax, Magnesium Sulfate, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL021 ArtworkPL021 Artwork

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60232-0021SKIN PROTECTANT CREAM 43% PETROLATUM (43% PETROLAUM SKIN PROTECTANT) CREAM [SWISS-AMERICAN CDMO, LLC]3Legacy NDC20231109_4bb13604-9ff2-4e81-ac26-f11ef50951a9.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60232-002160232-0021-4

Ingredients#

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

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

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
910f41e8-e7d8-41ec-91b0-606d7619e9164bb13604-9ff2-4e81-ac26-f11ef50951a92026-01-08WarningsExact identifier
spl set id: 4bb13604-9ff2-4e81-ac26-f11ef50951a9

Reported adverse events (FAERS/openFDA)#

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