PURE AND GENTLE- mineral oil enema 
Medline Industries, LP

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.

----------

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 not finalpart33404/09/2014
Labeler - Medline Industries, LP (025460908)

Revised: 9/2022
Document Id: e94a72e9-6878-1802-e053-2a95a90a60dd
Set id: 96d4cad5-0602-4c31-94ed-3117b4fd4a94
Version: 7
Effective Time: 20220922
 
Medline Industries, LP