Label: PURE AND GENTLE- mineral oil enema

  • NDC Code(s): 53329-013-11
  • Packager: Medline Industries, LP
  • 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 October 28, 2021

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

  • Active ingredient (in each 118 mL delivered dose)

    Mineral oil 100% w/v

  • Purpose

    Lubricant laxative

  • Uses

    • for relief of occasional constipation
    • this product generally produces bowel movement in 2 to 15 minutes
  • Warnings

    For rectal use only

    Caution: to be taken only at bedtime. Do not use at any other time or administer to infants, except upon the advice of a physician.

    Do not use

    • on children under 13 years of age
    • on pregnant women
    • on persons with difficulty swallowing
    • on bedridden patients
    • if you are presently taking a stool softener laxative
    • or take with meals

    Ask a doctor before use if you

    • have already used a laxative for more than 3 days
    • have abdominal pain, nausea or vomiting
    • have a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you have no bowel movement within 30 minutes of enema use

    As with any drug, if you are nursing a baby,

    seek the advice of a health professional before using this product.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • Directions (or as directed by a doctor)

    Rectal enema dosage is 120 mL in a single daily dosage (per 24 hours)

    adults & children

    13 years and over

    1 bottle

    children under 13 years of age

    DO NOT USE

    Caution:

    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

    Remove protective shield illustration

    Positioning:

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

    Left Side position illustration

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

    Knee-chest position illustration

    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. This product generally produces a bowel movement in 2 to 15 minutes.
    • Do not retain enema solution in body for longer than 15 minutes.
  • Other Information

    • store at room temperature 15-30°C (59-86°F)
    • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.
  • Inactive ingredient

    none

  • Questions or comments?

    1-866-323-0107

  • Manufacturing Information

    Manufactured for: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093

    Made in USA

    www.medline.com

    1-800-MEDLINE

    REF: CUR095010

    RD21NPX

  • Package Label

    53329-013

  • INGREDIENTS AND APPEARANCE
    PURE AND GENTLE 
    mineral oil enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-013
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL100 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-013-111 in 1 BOX04/09/2014
    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 finalpart33404/09/2014
    Labeler - Medline Industries, LP (025460908)