ENEMA MINERAL OIL- mineral oil enema 
Natureplex LLC

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.

----------

Enema Mineral Oil

Drug Facts

Active ingredient (in each 120 ml delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Use

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 persist 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: 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 old and older1 bottle
Children under 13 years oldDO NOT USE

Other information

Inactive ingredient

None

Questions or comments?

1-866-323-0107 or www.natureplex.com

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

*Compare To Fleet® Mineral Oil Enema

Natureplex™

READY TO USE

Enema

Mineral
Oil

Sodium
Free

For
Relief Of
Occasional
Constipation

Not Made
With
Natural
Rubber
Latex

Soft,
Easy To
Use
Bottle

NDC 67234-019-01

1
Bottle
4.5 Fl Oz
(133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton
ENEMA MINERAL OIL 
mineral oil enema
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67234-019
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil118 g  in 118 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67234-019-011 in 1 CARTON01/05/2013
1133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/05/2013
Labeler - Natureplex LLC (062808196)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex LLC062808196MANUFACTURE(67234-019)

Revised: 1/2020
Document Id: 93c3aa6d-aa45-4a56-84f5-6876db5b2572
Set id: 44ded8db-cace-416a-a15f-921fcdaa11bd
Version: 4
Effective Time: 20200116
 
Natureplex LLC