FDA.reportPublic FDA data

DawnMist Hypoallergenic Petroleum

Manufacturer
Donovan Industries, Inc.
Effective date
2011-09-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:40

Label at a glance#

ProductDawnMist Hypoallergenic Petroleum
Active ingredientPETROLATUM
Label structure10 sections

Indications and uses

Temporarily protects minor cuts, scraps or burns Temporarily protects ad helps relieve chapped or cracked skin and lips. Helps protect from the drying effects of wind and cold weather

Dosage and administration

Apply as often as necessary.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum, USP 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor cuts, scraps or burns
  • Temporarily protects ad helps relieve chapped or cracked skin and lips.
  • Helps protect from the drying effects of wind and cold weather

Warnings:

WARNINGS SECTION

For external use only.

Do not use on:

OTC - DO NOT USE SECTION

  • deep puncture wounds
  • lacerations or infections
  • serious burns
  • animal bites

Stop use and ask doctor

OTC - STOP USE SECTION

  • if condition does not improve or lasts more than 7 days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed get medical help or contact Poison Control Center right away
  • If redness or swelling develops, consult a physician promptly

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as often as necessary.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

SPL UNCLASSIFIED SECTION

Manufactured for:
Donovan Industries, Inc.
Tampa, FL 33623-3061
800.334.4404
Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hypoallergenic

Soothes and Moisturizes


DawnMist

Hypoallergenic Petroleum Jelly

Product Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Petroleum Jelly LabelPetroleum Jelly Label

Outer Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Petroleum Jelly LabelPetroleum Jelly Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN1
204754petrolatum 1 MG/MG Topical OintmentSCD1
204754petrolatum 100 % Topical JellySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55504-0432-12019-10-29C16284748780-1960f7f55-d2e0-8e05-e053-dbdaa90a074aDawnMist Hypoallergenic Petroleum Jelly
55504-0432-22019-10-29C16284748780-1960f7f55-d2e0-8e05-e053-dbdaa90a074aDawnMist Hypoallergenic Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55504-0432-1DawnMist Hypoallergenic Petroleum144 in 1 BOXJELLY1441
55504-0432-1DawnMist Hypoallergenic Petroleum56 g in 1 TUBEJELLY561
55504-0432-2DawnMist Hypoallergenic Petroleum56 g in 1 TUBEJELLY561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55504-0432DAWNMIST HYPOALLERGENIC PETROLEUM (PETROLATUM) JELLY [DONOVAN INDUSTRIES, INC.]1Legacy NDC, 3 package rows20110928_0f56b541-4482-4490-bde2-23524fb0d973.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

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
55504-043255504-0432-2, 55504-0432-1

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
cd42069d-01be-4b52-90ae-0ad7a7fd0b300f56b541-4482-4490-bde2-23524fb0d9732011-09-27WarningsExact identifier
spl id: cd42069d-01be-4b52-90ae-0ad7a7fd0b30
spl set id: 0f56b541-4482-4490-bde2-23524fb0d973

Reported adverse events (FAERS/openFDA)#

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