FDA.reportPublic FDA data

Mineral Oil

Manufacturer
Rebel Distributors Corp
Effective date
2011-02-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:43

Label at a glance#

ProductMineral Oil
Active ingredientMINERAL OIL, PETROLATUM
Label structure9 sections

Indications and uses

For use as a protectant against further irritation or to relieve dryness or the eye.

Dosage and administration

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 42.5%

White Petrolatum 56.8%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

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

For use as a protectant against further irritation or to relieve dryness or the eye.

Warnings

WARNINGS SECTION

For external use only.

To avoid contamination, do not touch tip of container to any surface.

Replace cap after using.

Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Directions

DOSAGE & ADMINISTRATION SECTION

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

SPL UNCLASSIFIED SECTION

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

Store away from heat. Protect from freezing.

Use before expiration date marked on container.

RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Chlorobutanol and lanolin alcohols.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lacri-LubeLacri-Lube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
701984mineral oil 42.5 % / petrolatum 56.8 % Ophthalmic OintmentPSN1
701984mineral oil 0.425 MG/MG / petrolatum 0.568 MG/MG Ophthalmic OintmentSCD1
701984mineral oil 42.5 % / petrolatum, white 56.8 % Ophthalmic OintmentSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-681-072019-09-24C16284748780-1934fe258-4794-48b1-e053-8cdaa90a720aLacri-Lube Drug Facts
21695-681-352019-09-24C16284748780-1934fe258-4794-48b1-e053-8cdaa90a720aLacri-Lube Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-681-07Mineral Oil7 g in 1 TUBEOINTMENT71
21695-681-35Mineral Oil3.5 g in 1 TUBEOINTMENT3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-681MINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110413_3f0ec253-6179-4609-8a67-00dbefc55033.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-681-07GM - Gram21695-6812a7626be-2f9c-420b-9478-430335b5ca7912012-07-24
21695-681-35GM - Gram21695-681d4e50218-7170-49d6-ad6f-c923c7056a8712012-07-24
0023-0312-04GM - Gram0023-031220b39866-d70e-43a9-aba4-f2788fd84ed812012-07-24
0023-0312-07GM - Gram0023-0312908fe98b-82bb-4d73-892c-9c93a24b96d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRC1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HE1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-68121695-681-35, 21695-681-07
0023-0312

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
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB
CHLOROBUTANOLHM4YQM8WRCIACT
LANOLIN ALCOHOLS884C3FA9HEIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CHLOROBUTANOLCHLOROBUTANOLHM4YQM8WRCOINTMENT / OPHTHALMIC0.65 %w/wExact identifier — unii+route+dosage form
LANOLIN ALCOHOLSLANOLIN ALCOHOLS884C3FA9HEOINTMENT / OPHTHALMIC10 %w/wExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
ndc (product): 0023-0312
3f0ec253-6179-4609-8a67-00dbefc550333f0ec253-6179-4609-8a67-00dbefc550332011-02-17WarningsExact identifier
spl id: 3f0ec253-6179-4609-8a67-00dbefc55033
spl set id: 3f0ec253-6179-4609-8a67-00dbefc55033

Reported adverse events (FAERS/openFDA)#

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