FDA.reportPublic FDA data

OraLabs ChapIce Original Petrolatum

Manufacturer
OraLabs
Effective date
2025-04-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:09

Label at a glance#

ProductOraLabs ChapIce Original Petrolatum
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

Helps prevent and temporarily protect dry, chapped or windburned lips.

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum, 45%

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

Helps prevent and temporarily protect dry, chapped or windburned lips.

Warnings

WARNINGS SECTION

For external use only. Stop use and ask a doctor if rash or irritation develops and lasts. Children under 6 months of age: Ask a doctor before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Camphor, Cetyl Alcohol, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Isopropyl Myristate, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Phenyl Trimethicone, Red 6 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ChapIce Original Petrolatum
ChapIce Original Petrolatum

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63645-169-062025-04-30C16284748780-12cef2736-a6df-d83d-e063-dadaa90ab31fDrug Facts
63645-169-062025-01-30C16284748780-12cef2736-a6df-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63645-169-06OraLabs ChapIce Original Petrolatum1 g in 1 CONTAINERSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63645-169ORALABS CHAPICE ORIGINAL PETROLATUM (PETROLATUM) STICK [ORALABS]3Current NDC, Legacy NDC, 1 package rows20250502_54729693-f0e2-48ad-881a-a07986ed823b.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
63645-16963645-169-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIGHT MINERAL OILN6K5787QVPIACT
WHITE WAX7G1J5DA97FIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
LANOLIN7EV65EAW6HIACT
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
OraLabs ChapIce Original PetrolatumPETROLATUMOraLabs54729693-f0e2-48ad-881a-a07986ed823b2025-04-30WarningsExact identifier
ndc (package): 63645-169-06
ndc (product): 63645-169
ndc11 (package): 63645016906
spl id: 340695fd-975e-d58a-e063-6294a90a75c9
spl set id: 54729693-f0e2-48ad-881a-a07986ed823b

Reported adverse events (FAERS/openFDA)#

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