Label: LEADER MINERAL OIL- mineral oil enema
- 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.
Updated July 8, 2015
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- Active ingredient
For rectal use only
Ask a doctor before use if you have
- abdominal pain, nausea or vomiting
- notice 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 or failure to have a bowel movement after use of a laxative because this may indicate a serious condition
- you need to use a laxative for more than one week
Single daily dose
adults & children
12 years and over
1 bottle once daily
children 2 to under
1/2 bottle once daily
Discard unused portion
do not use
How to use this enema:
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.
Left-side position: Lie on left side with knee bent and arms at rest.
Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.
- 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.
- Retain enema in accordance with doctor's instructions.
- Other Information
- Inactive ingredient
- Questions or comments?
- Principal Display Panel
- Side and Back Panel - Box
INGREDIENTS AND APPEARANCE
LEADER MINERAL OIL
mineral oil enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-755 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 118 mL in 118 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-755-11 1 in 1 BOX 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 02/19/2013 Labeler - CARDINAL HEALTH, INC. (097537435)