Pure and Gentle 100 g/100mL
mineral oil · ENEMA · Medline Industries, LP
Pure and Gentle is a enema containing mineral oil at 100 g/100mL, taken rectal. Manufactured by Medline Industries, LP.
Key Facts
- Brand Name
- Pure and Gentle
- Generic Name
- mineral oil
- NDC Code (Product)
53329-013- Manufacturer
- Medline Industries, LP
- Strength
- 100 g/100mL
- Dosage Form
- ENEMA
- Route
- RECTAL
- Marketing Status
- Application #
- M007
- Marketing Start
- 04/09/2014
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses for relief of occasional constipation this product generally produces bowel movement in 2 to 15 minutes
Dosage & Administration
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 …
Warnings
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)
Frequently Asked Questions
What is Pure and Gentle used for?
Pure and Gentle contains mineral oil. It is a enema taken rectal. Consult your doctor for specific uses.
Is Pure and Gentle a controlled substance?
Pure and Gentle is not classified as a controlled substance by the DEA.
What is the generic name for Pure and Gentle?
The generic name for Pure and Gentle is mineral oil. There are 11 other brand versions of mineral oil.
What is the NDC code for Pure and Gentle 100 g/100mL?
The NDC (National Drug Code) for Pure and Gentle 100 g/100mL is 53329-013, listed by Medline Industries, LP.
Other Mineral Brands
See all →- Hemorrhoidal14 g/100g85766-140
- Hemorrhoidal14 g/100g11822-0006
- Signature Care Hemorrhoidal140 mg/g21130-789
- REFRESH LACRI-LUBE425 mg/g0023-0312
- CAREALL Hemorrhoidal140 mg/g51824-079
- HemorrhoidalOintment14 g/100g69396-083
- Family wellness14 g/100g69571-006
- Mineral Oil999 mg/mL70000-0663
- Equaline Hemorrhoidal14 g/100g41163-188
- Sunmark Mineral Oil Laxative118 g/118mL49348-185
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)