Leader Ready To Use Mineral Oil Enema
FDA Label NDC 70000-0109

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Leader Ready To Use Mineral Oil (NDC 70000-0109). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each 118 ml delivered dose), purpose, uses, warnings, ask a doctor before use, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

Active Ingredient (In Each 118 Ml Delivered Dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

  • for relief of occasional constipation
  • for relief of fecal impaction
  • for removal of residue after barium administration

Warnings

For rectal use only

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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)

Directions

Single daily dose (per 24 hours).

adults & children 12 years and over1 bottle once daily
children 2 to under 12 years1/2 bottle once daily discard unused portion
children under 2 yearsDO 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

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)

Principal Display Panel (133 mL Bottle Carton)

Principal Display Panel (133 mL Bottle Carton)

* Please review the disclaimer below.