FDA.reportPublic FDA data

WHITE PETROLATUM

Manufacturer
STRATUS PHARMACEUTICALS INC | TARMAC PRODUCTS INC
Effective date
2022-11-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:47:24

Label at a glance#

ProductWHITE PETROLATUM
Active ingredientPETROLATUM
Label structure11 sections

Dosage and administration

Cleanse area with mild soap and water. Apply White Petrolatum liberally generously to affected area.

Storage and handling

Store at room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Indications

INDICATIONS & USAGE SECTION

For the temporary protection of minor cuts, scrapes, abrasions, burns, sunburns, chafed or chapped skin. Helps treat and prevent diaper rash.

Caution

SPL UNCLASSIFIED SECTION

In case of deep or puncture wounds or severe burns, consult a physician. If irritation, swelling or pain persists, or if infection occurs, discontinue use and consult a physician.

For external use only.

Warnings

WARNINGS SECTION

Do not use in the eyes.

If swallowed, get medical help or contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse area with mild soap and water.

Apply White Petrolatum liberally generously to affected area.

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15°C-30°C (59°F-86°F). Avoid excessive heat.

Description

SPL UNCLASSIFIED SECTION

White Petrolatum USP is a first aid ointment that protects and revitalizes chapped and cracked skin areas. It contains 100% White Petrolatum USP to help seal moisture into the skin. White Petrolatum USP Ointment can be applied to minor skin injuries including cuts, scrapes, rashes and burns. Each pouch contains a 5g unit dose individually sealed and barcoded.

SPL UNCLASSIFIED SECTION

Distributed by: Stratus Pharmaceuticals Inc., Miami, FL 33186

OTC - QUESTIONS SECTION

Toll Free: 1-800-442-7882

PRINCIPAL DISPLAY PANEL - 5 g Packet Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 58980-350-50

White Petrolatum USP
Ointment

Skin Protectant
Smooths skin irritations due to:
▪ minor burns   ▪ scrapes   ▪ abrasions

STRATUS
PHARMACEUTICALS INC

Contains:
144 packets / 5g each

PRINCIPAL DISPLAY PANEL - 5 g Packet Box
PRINCIPAL DISPLAY PANEL - 5 g Packet Box

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-350-50GM - Gram58980-350b15fd485-171c-41a2-bb5e-e12cdd1da38b12019-10-07

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58980-35058980-350-50

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB

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
79f63b6d-a22b-40c2-99c9-881b013c5a7cc8c1b96e-cc12-495f-a027-8c7c9bcda3742024-10-31WarningsExact identifier
spl set id: c8c1b96e-cc12-495f-a027-8c7c9bcda374

Reported adverse events (FAERS/openFDA)#

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