FDA.reportPublic FDA data

Hydrolatum

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2023-10-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:56:36

Label at a glance#

ProductHydrolatum
Active ingredientPETROLATUM
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum, 54%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked skin
  • helps prevent and protect from the drying effects of wind and cold weather

WARNINGS SECTION

  • for external use only
  • Keep out of reach of children
  • Stop using if allergic

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not get into mouth

OTC - STOP USE SECTION

  • if condition lasts more than 7 days

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

OTHER SAFETY INFORMATION

  • Store at 20-25C (68-77F)

INACTIVE INGREDIENT SECTION

Methylparaben, Purified Water, Sorbitan Sesquioleate

TROUBLESHOOTING

Call Toll Free at 1-800-601-3843 or email complaints@dpharm.net

OTC - DO NOT USE SECTION

  • deep or punctured wounds
  • animal bites
  • serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0295-9011-13Hydrolatum57 g in 1 TUBECREAM574
0295-9011-36Hydrolatum454 g in 1 JARCREAM4544
0295-9011-69Hydrolatum340 g in 1 JARCREAM3404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0295-9011HYDROLATUM (WHITE PETROLATUM) CREAM [DENISON PHARMACEUTICALS, LLC]4Legacy NDC, 3 package rows20231011_9ef53da4-8f1f-46b0-e053-2995a90aa7a6.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90110295-9011-13, 0295-9011-36, 0295-9011-69

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
PETROLATUM4T6H12BN9UACTIB
METHYLPARABENA2I8C7HI9TIACT

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
076a60f5-891f-df35-e063-6394a90a7a9b9ef53da4-8f1f-46b0-e053-2995a90aa7a62023-10-11WarningsExact identifier
spl id: 076a60f5-891f-df35-e063-6394a90a7a9b
spl set id: 9ef53da4-8f1f-46b0-e053-2995a90aa7a6

Reported adverse events (FAERS/openFDA)#

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