FDA.reportPublic FDA data

Skin-lube

Manufacturer
The Hygenic Company, LLC.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:08

Label at a glance#

ProductSkin-lube
Active ingredientPETROLATUM, DIMETHICONE
Label structure11 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.

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 a few days.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other Information

SPL UNCLASSIFIED 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:82345-860-25

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:82345-860-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling:82345-860-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Package Labeling:82345-860-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1923343dimethicone 1.5 % / petrolatum 85 % Topical OintmentPSN2
2597544Skin-Lube 1.5 % / 85 % Topical OintmentPSN2
2597544dimethicone 0.015 MG/MG / petrolatum 0.85 MG/MG Topical Ointment [Skin-Lube]SBD2
1923343dimethicone 0.015 MG/MG / petrolatum 0.85 MG/MG Topical OintmentSCD2
1923343dimethicone 1.5 % / petrolatum 85 % Topical OintmentSY2
2597544Skin-Lube (dimethicone 1.5 % / petrolatum 85 % ) Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82345-860-01Skin-lube454 g in 1 BOTTLEOINTMENT4542
82345-860-02Skin-lube78 g in 1 JAROINTMENT782
82345-860-05Skin-lube2270 g in 1 BOTTLEOINTMENT22702
82345-860-25Skin-lube1134 g in 1 BOTTLEOINTMENT11342

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82345-860SKIN-LUBE (PETROLATUM, DIMETHICONE) OINTMENT [THE HYGENIC COMPANY, LLC.]2Current NDC, Legacy NDC, 4 package rows20231106_d1005dec-04f6-3f88-e053-2a95a90ad9cb.zip

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
82345-86082345-860-25, 82345-860-05, 82345-860-01, 82345-860-02

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
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
ZINC STEARATEH92E6QA4FVIACT
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
Skin-lubePETROLATUM, DIMETHICONEThe Hygenic Company, LLC.d1005dec-04f6-3f88-e053-2a95a90ad9cb2023-11-05WarningsExact identifier
ndc (package): 82345-860-25
ndc (package): 82345-860-01
ndc (package): 82345-860-05
ndc (package): 82345-860-02
ndc (product): 82345-860
ndc11 (package): 82345086002
ndc11 (package): 82345086005
ndc11 (package): 82345086001
ndc11 (package): 82345086025
spl id: 0973a822-e675-feb3-e063-6294a90ab132
spl set id: d1005dec-04f6-3f88-e053-2a95a90ad9cb

Reported adverse events (FAERS/openFDA)#

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