Pure And Gentle Enema
FDA Label NDC 53329-013

15 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Pure And Gentle (NDC 53329-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 120 ml delivered dose), purpose, uses, warnings, do not use, ask a doctor before use if you, stop use and ask a doctor if, as with any drug, if you are nursing a baby,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 120 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.

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 (4d1f9fb5 Bfd2 4497 89cb 0bfed7635ea0 01)

Remove Protective Shield Illustration (4d1f9fb5 Bfd2 4497 89cb 0bfed7635ea0 01)

Positioning:

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

Left Side Position Illustration (4d1f9fb5 Bfd2 4497 89cb 0bfed7635ea0 02)

Left Side Position Illustration (4d1f9fb5 Bfd2 4497 89cb 0bfed7635ea0 02)

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 (4d1f9fb5 Bfd2 4497 89cb 0bfed7635ea0 03)

Knee-chest Position Illustration (4d1f9fb5 Bfd2 4497 89cb 0bfed7635ea0 03)

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

* Please review the disclaimer below.