FDA.reportPublic FDA data

Leader Mineral Oil

Manufacturer
CARDINAL HEALTH, INC.
Effective date
2015-07-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:31:19

Label at a glance#

ProductLeader Mineral Oil
Active ingredientMINERAL OIL
Label structure10 sections

Indications and uses

• for relief of occasional constipation

Dosage and administration

Single daily dose adults & children 12 years and over 1 bottle once daily children 2 to under 12 years 1/2 bottle once daily Discard unused portion children under 2 years do not use How to use this enema: REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE. Positioning: Left-side position: Lie on l...

Storage and handling

• store at room temperature 20-25 deg C (68-77 deg F) • this product generally produces bowel movement in 2-15 minutes

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 118 mL delivered dose)

Mineral oil 100%

Purpose

OTC - PURPOSE SECTION

Lubricant laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation

Warnings

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
  • you need to use a laxative for more than one week

If pregnant or breastfeeding, ask a health professional before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Single daily dose

adults & children

12 years and over

1 bottle once daily

children 2 to under

12 years

1/2 bottle once daily

Discard unused portion

children under

2 years

do not use

How to use this enema:

REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.

Hand Positioning
Hand Positioning

Positioning:

Left-side position: Lie on left side with knee bent and arms at rest.

Left-side Positioning
Left-side Positioning

Knee-chest position:

Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.

Knee-chest Positioning
Knee-chest Positioning

Administering enema:

  • With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.
  • Do not force the enema tip into rectum as this can cause injury.
  • Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed.
  • Remove enema tip from rectum.
  • Retain enema in accordance with doctor's instructions.

Other Information

STORAGE AND HANDLING SECTION

  • store at room temperature 20-25 deg C (68-77 deg F)
  • this product generally produces bowel movement in 2-15 minutes

Inactive ingredient

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-800-633-5463

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader

Compare to Fleet® Mineral Oil Enema active ingredient

Ready-To-Use

Enema Mineral Oil

Sodium Free Lubricant

Laxative For Relief

of Occasional Constipation

Comfortable, Lubricated Tip

Works In Minutes

Latex Free

Satisfaction Guaranteed

4.5 FL OZ (133ml)

Principal Display Panel
Principal Display Panel

Side and Back Panel - Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER MINERAL OIL ENEMA DRUG FACTS
LEADER MINERAL OIL ENEMA DRUG FACTS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-755-112025-05-07C16284748780-19d75b9d1-2139-f424-e053-dadaa90a57ceDrug Facts
37205-755-112020-01-31C16284748780-19d75b9d1-2139-f424-e053-dadaa90a57ceDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-755-11ML - Milliliter37205-7551d6b77eb-e7aa-481d-8fa3-4e492b63ee5612014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP3
MINERAL OILACTIVE MOIETYT5L8T28FGP3

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-75537205-755-11

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB

Source Document#

Source XML · Source PDF

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
2b5b894a-0450-4968-bd9e-3e702e0480d3ab752f48-277c-4ed0-8167-ef22f89b56bd2025-04-24WarningsExact identifier
spl set id: ab752f48-277c-4ed0-8167-ef22f89b56bd

Reported adverse events (FAERS/openFDA)#

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