Label: LEADER READY TO USE MINERAL OIL LAXATIVE- mineral oil enema

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 21, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

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

    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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • 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
  • INGREDIENTS AND APPEARANCE
    LEADER READY TO USE MINERAL OIL   LAXATIVE
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0109
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL118 g  in 118 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0109-11 in 1 CARTON02/19/2013
    1133 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33402/19/2013
    Labeler - Cardinal Health (063997360)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(70000-0109)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!