Label: ENEMA- mineral oil enema

  • NDC Code(s): 50730-2113-0
  • Packager: H and P Industries, Inc. dba Triad Group
  • 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 November 3, 2009

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  • Active ingredient

    Mineral Oil, 100%

  • Purpose

    Lubricant Laxative

  • Use

    • For relief of occasional constipation. This product generally produced bowel movement in 2 to 15 minutes.
  • Warnings

    For rectal use only.

    Do not use

    • If you have abdominal pain, nausea, or vomiting, unless directed by a doctor.
    • Longer than one week unless directed by a doctor.
    • More than one enema per day unless directed by a doctor.

    Ask a doctor before use

    • if you have noticed a sudden change in bowel habits that persist over a period of 2 weeks

    Stop use and ask a doctor if

    • use results in unusual pain or other side effects.
    • you have rectal bleeding or failure to have a bowel movement after use of a laxative. This may indicate a serious condition.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Single Daily Dose

    Do not use more unless directed by a doctor.
    See Warnings.

    Adults and children
    12 years and older
    One bottle (4 oz.)
    120 mL delivered dose
    Children 2 years to
    12 years old
    1/2 Adult dose (2 oz.)
    60 mL delivered dose
    Children under
    2 years of age
    Ask a doctor

    • Adults and children 12 years of age and older: rectal enema dosage is 120 milliliters in a single daily dose.
    • Children 2 to 12 years of age: rectal enema dosage is 60 mililiters in a single daily dose, 1/2 of a bottle. (Children's dose of 60 mililiters can be measured by removing mineral oil from the bottle until the words "Mineral Oil" on the front face of the bottle are just covered).
    • Children under 2 years of age: ask a doctor.
    Directions for inserting enema

    Left side position: Lie on left side with right knee bent and arms resting comfortably.

    Knee chest position: Kneel, lower head and chest forward until left side of the face is resting on surface with arms resting comfortably.

    CAUTION: Remove orange protective shield before inserting. To do so, hold bottle upright with one hand and pull gently to remove.

    • with steady pressure, gently insert enema tip into rectum with a side to side movement with tip pointing toward navel.
    • stop using if tip is hard to insert. Forcing tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.
    • Squeeze bottle until nearly all the liquid is released. Remove from rectum. Maintain position until urge to evacuate is strong (usually 1 to 5 minutes). If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

  • Other Information

    This product does not contain Dry Natural Rubber or Natural Rubber Latex.




  • Principal Display Panel


    enema, USP

    protective shield prevents contamination

    lubricated tip assures ease of insertion

    one way safety valve prevents reflux

    easy to grip and squeeze bottle

    carton sealed for safety

    4 1/2 fl. oz. (133 ml)

    CAT. No. 10-2113
    Triad Disposables
    Brookfield, WI 53045

    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-2113
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    mineral oil (UNII: T5L8T28FGP) (mineral oil - UNII:T5L8T28FGP) mineral oil118 mL  in 118 mL
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-2113-01 in 1 BOX
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/22/1996
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture