PURE AND GENTLE- mineral oil enema 
Medline Industries, LP

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013 Pure & Gentle Mineral Oil Enema

Active ingredient
(in each 120 mL delivered dose)

Mineral oil 100% w/v

Purpose

Lubricant laxative

Uses

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:

Other Information

Inactive ingredient

none

Questions or comments?

1-866-323-0107 M-F 8 am to 5 pm

Manufacturing Information

Manufactured for: Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093

Made in USA

www.medline.com

1-800-MEDLINE (633-5463)

REF: CUR095010

V1 RD22NPX

Package Label

label

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 DrugM00704/09/2014
Labeler - Medline Industries, LP (025460908)

Revised: 11/2024
Document Id: 27d437bf-4b2b-eb33-e063-6394a90a4ef6
Set id: 96d4cad5-0602-4c31-94ed-3117b4fd4a94
Version: 8
Effective Time: 20241126
 
Medline Industries, LP