FDA.reportPublic FDA data

Skin-Lube Ointment

Manufacturer
Performance Health, LLC
Effective date
2022-08-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:55:46

Label at a glance#

ProductSkin-Lube
Active ingredientPETROLATUM, DIMETHICONE
Label structure8 sections

Indications and uses

Temporarily protects minor - cuts  - scrapes  - burns  -- Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin.  Helps prevent and protect from the drying effects of wind and cold weather.

Dosage and administration

Apply as needed. If swallowed, get medical help or contact a Poison Control Center right away.

Storage and handling

Store in a cool dry place with lid closed tightly

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

​Petrolatum 85%

Dimethicone 1.5%

Purpose

OTC - PURPOSE SECTION

​Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects minor - cuts  - scrapes  - burns  -- Helps prevent, temporarily protects, and helps relieve chafed, chapped or cracked skin.  Helps prevent and 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 or puncture wounds  - animal bites  - serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

- condition worsens  - symptoms last more than 7 days or clear up and occur again within few days.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Information:

STORAGE AND HANDLING SECTION

Store in a cool dry place with lid closed tightly

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Diazolidinyl Urea, Methylparaben, Propylene Glycol, Propylparaben, Zinc Stearate

Questions?

OTC - QUESTIONS SECTION

(800) 345-2231

Package Labeling: 59316-995-95

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label11Label11

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
59316-99559316-995-21, 59316-995-95, 59316-995-96, 59316-995-97

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
ZINC STEARATEH92E6QA4FVIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PETROLATUM4T6H12BN9UACTIB
DIMETHICONE92RU3N3Y1OACTIB

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
e5b3695c-7190-66de-e053-2a95a90a68c5eb42e07b-5a09-44b9-a601-f1fa0b7f61482022-08-07WarningsExact identifier
spl id: e5b3695c-7190-66de-e053-2a95a90a68c5
spl set id: eb42e07b-5a09-44b9-a601-f1fa0b7f6148

Reported adverse events (FAERS/openFDA)#

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