Leader®

Leader®
SPL v6
SPL
SPL Set ID b8494d02-8a7d-47b4-80b0-b8ab51b625fd
Route
RECTAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (118 g)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-02-19 Until 2026-11-30
Description

Drug Facts

Purpose

Lubricant laxative

Medication Information

Purpose

Lubricant laxative

Description

Drug Facts

Uses
  • for relief of occasional constipation
  • for relief of fecal impaction
  • for removal of residue after barium administration
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 53414-9

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

Warnings

For rectal use only

Directions

Single daily dose (per 24 hours).

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
Other Information
  • store at 15°-30°C (59°-86°F)
  • this product generally produces a bowel movement in 2 to 15 minutes
Inactive Ingredients

none

Questions Or Comments?

1-866-323-0107

Ask A Doctor Before Use
  • if you have abdominal pain, nausea, or vomiting
  • if you have a sudden change in bowel habits that persists over a period of 2 weeks
  • if you have already used a laxative for more than 1 week
  • if constipation continues after one week of use, contact your doctor
Stop Use and Ask A Doctor If
  • you have rectal bleeding or no bowel movement within 15 minutes of using this product
  • you need to use a laxative for more than one week

These symptoms may indicate a serious condition.

Principal Display Panel 133 Ml Bottle Carton

LEADER™

NDC 70000-0109-1

Ready-To-Use

Enema

Mineral Oil

Lubricant Laxative

Sodium Free

For Relief Of:

Occasional

Constipation

Comfortable,

Lubricated Tip

Works in

Minutes

Not Made

With Natural

Rubber

Latex

COMPARE TO

FLEET® MINERAL

OIL ENEMA

active ingredient*

1 BOTTLE

100% Money

Back Guarantee

4 .5 FL OZ (133 mL)

Active Ingredient (in Each 118 Ml Delivered Dose)

Mineral oil 100%

Structured Label Content

Uses
  • for relief of occasional constipation
  • for relief of fecal impaction
  • for removal of residue after barium administration
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 53414-9 (53414-9)

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

Purpose

Lubricant laxative

Warnings

For rectal use only

Directions

Single daily dose (per 24 hours).

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
Other Information (Other information)
  • store at 15°-30°C (59°-86°F)
  • this product generally produces a bowel movement in 2 to 15 minutes
Inactive Ingredients (Inactive ingredients)

none

Questions Or Comments? (Questions or comments?)

1-866-323-0107

Ask A Doctor Before Use (Ask a doctor before use)
  • if you have abdominal pain, nausea, or vomiting
  • if you have a sudden change in bowel habits that persists over a period of 2 weeks
  • if you have already used a laxative for more than 1 week
  • if constipation continues after one week of use, contact your doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or no bowel movement within 15 minutes of using this product
  • you need to use a laxative for more than one week

These symptoms may indicate a serious condition.

Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton)

LEADER™

NDC 70000-0109-1

Ready-To-Use

Enema

Mineral Oil

Lubricant Laxative

Sodium Free

For Relief Of:

Occasional

Constipation

Comfortable,

Lubricated Tip

Works in

Minutes

Not Made

With Natural

Rubber

Latex

COMPARE TO

FLEET® MINERAL

OIL ENEMA

active ingredient*

1 BOTTLE

100% Money

Back Guarantee

4 .5 FL OZ (133 mL)

Active Ingredient (in Each 118 Ml Delivered Dose) (Active ingredient (in each 118 mL delivered dose))

Mineral oil 100%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.621688 · Updated: 2026-03-14T23:10:23.192014