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 September 22, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each 120 mL delivered dose)
- Purpose
- 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
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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
Positioning:
Left-side position: Lie on left side with knee bent and arms at rest.
Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
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
- Inactive ingredient
- Questions or comments?
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
PURE AND GENTLE
mineral oil enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-013 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 100 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-013-11 1 in 1 BOX 04/09/2014 1 133 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 04/09/2014 Labeler - Medline Industries, LP (025460908)
