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NDC 67234-0019-01 Enema Mineral Oil 118 g/118mL Details

Enema Mineral Oil 118 g/118mL

Enema Mineral Oil is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Natureplex LLC. The primary component is MINERAL OIL.

Product Information

NDC	67234-0019
Product ID	67234-019_93c3aa6d-aa45-4a56-84f5-6876db5b2572
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Enema Mineral Oil
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral Oil
Product Type	HUMAN OTC DRUG
Dosage Form	ENEMA
Route	RECTAL
Active Ingredient Strength	118
Active Ingredient Units	g/118mL
Substance Name	MINERAL OIL
Labeler Name	Natureplex LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 67234-0019-01 (67234001901)

Pricing Information	N/A
NDC Package Code	67234-019-01
Billing NDC	67234001901
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (67234-019-01) / 133 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2013-01-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 44ded8db-cace-416a-a15f-921fcdaa11bd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 120 ml delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Use

for relief of occasional constipation
this product generally produces bowel movement in 2 to 15 minutes

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 older	1 bottle
Children under 13 years old	DO NOT USE

Other information

Store at 15 to 30°C (59 to 86°F).
Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

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

INGREDIENTS AND APPEARANCE

ENEMA MINERAL OIL

mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67234-019
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	118 g in 118 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67234-019-01	1 in 1 CARTON	01/05/2013
1		133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/05/2013

Labeler - Natureplex LLC (062808196)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(67234-019)

Revised: 1/2020

Document Id: 93c3aa6d-aa45-4a56-84f5-6876db5b2572

Set id: 44ded8db-cace-416a-a15f-921fcdaa11bd

Version: 4

Effective Time: 20200116