PURE AND GENTLE- mineral oil enema

Pure and Gentle by

Drug Labeling and Warnings

Pure and Gentle by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

(in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

• for relief of occasional constipation

Warnings

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

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Do not use more unless directed by a doctor.

See Warnings.

• adults & children 12 years and over:

  1 bottle once daily

• children 2 to under 12 years:

  1/2 bottle once daily

  Discard unused portion

• children under 2 years:

  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

• store at room temperature 20-25 deg C (68-77 deg F)
• this product generally produces bowel movement in 2-15 minutes

Inactive ingredient

none

Questions or comments?

1-800-633-5463

Package Label

INGREDIENTS AND APPEARANCE

PURE AND GENTLE 
mineral oil enema

Product 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, Inc. (025460908)