FDA.reportPublic FDA data

Leader Lip Treatment

Manufacturer
Cardinal Health (Leader) | OraLabs
Effective date
2014-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:36:37

Label at a glance#

ProductLeader Lip Treatment
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum, 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

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.

Uses

INDICATIONS & USAGE SECTION

Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.

Warnings

WARNINGS SECTION

For external use only. When using this product –Do not get into eyes. Stop use and ask a doctor if – condition worsens-symptoms last more than 7 days or clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Flavor

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Petroleum Jelly Lip Treatment TubeLeader Petroleum Jelly Lip Treatment Tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49781-111-352025-05-16C16284748780-19d75b9d0-a867-f424-e053-dadaa90a57ceDrug Facts
49781-111-352020-01-31C16284748780-19d75b9d0-a867-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49781-11149781-111-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
METHYL SALICYLATELAV5U5022YIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 equally ranked IID candidates

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
fcbed059-2784-47d0-820e-3ee57b28d330b5cce596-b285-4cf9-a5c8-1bdeadfc245b2025-05-13WarningsExact identifier
spl set id: b5cce596-b285-4cf9-a5c8-1bdeadfc245b

Reported adverse events (FAERS/openFDA)#

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