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NDC 70000-0109-01 Leader Ready to Use Mineral Oil 118 g/118mL Details

Leader Ready to Use Mineral Oil 118 g/118mL

Leader Ready to Use Mineral Oil is a RECTAL ENEMA in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is MINERAL OIL.

Product Information

NDC	70000-0109
Product ID	70000-0109_910137c1-0d26-40d8-9898-0d39c1a5e8e7
Associated GPIs	46400010005110
GCN Sequence Number	002996
GCN Sequence Number Description	mineral oil ENEMA RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	09049
HICL Sequence Number	001319
HICL Sequence Number Description	MINERAL OIL
Brand/Generic	Generic
Proprietary Name	Leader Ready to Use Mineral Oil
Proprietary Name Suffix	Laxative
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	Cardinal Health
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 70000-0109-01 (70000010901)

Pricing Information
NDC Package Code	70000-0109-1
Billing NDC	70000010901
Package	1 BOTTLE in 1 CARTON (70000-0109-1) / 133 mL in 1 BOTTLE
Marketing Start Date	2013-02-19
NDC Exclude Flag	N
Price Per Unit	0.01433
Pricing Unit	ML
Effective Date	2023-08-23
NDC Description	READY TO USE MINERAL OIL ENEMA
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL b8494d02-8a7d-47b4-80b0-b8ab51b625fd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 118 mL delivered dose)

Mineral oil 100%

Purpose

Lubricant laxative

Uses

for relief of occasional constipation
for relief of fecal impaction
for removal of residue after barium administration

Warnings

For rectal use only

Ask a doctor before use

if you have abdominal pain, nausea, or vomiting
if you have a sudden change in bowel habits that persists over a period of 2 weeks
if you have already used a laxative for more than 1 week
if constipation continues after one week of use, contact your doctor

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement within 15 minutes of using this product
you need to use a laxative for more than one week

These symptoms may indicate a serious condition.

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

Keep out of reach of children to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Single daily dose (per 24 hours).

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

Other information

store at 15°-30°C (59°-86°F)
this product generally produces a bowel movement in 2 to 15 minutes

Inactive ingredients

none

Questions or comments?

1-866-323-0107

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

LEADER™

NDC 70000-0109-1

Ready-To-Use

Enema

Mineral Oil

Lubricant Laxative

Sodium Free

For Relief Of:

Occasional

Constipation

Comfortable,

Lubricated Tip

Works in

Minutes

Not Made

With Natural

Rubber

Latex

COMPARE TO

FLEET® MINERAL

OIL ENEMA

active ingredient*

1 BOTTLE

100% Money

Back Guarantee

4 .5 FL OZ (133 mL)

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

INGREDIENTS AND APPEARANCE

LEADER READY TO USE MINERAL OIL LAXATIVE

mineral oil enema

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0109
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:70000-0109-1	1 in 1 CARTON	02/19/2013
1		133 mL in 1 BOTTLE; 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	02/19/2013

Labeler - Cardinal Health (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
Natureplex LLC		062808196	MANUFACTURE(70000-0109)

Revised: 6/2021

Document Id: 910137c1-0d26-40d8-9898-0d39c1a5e8e7

Set id: b8494d02-8a7d-47b4-80b0-b8ab51b625fd

Version: 3

Effective Time: 20210621

Search by Drug Name or NDC

NDC 70000-0109-01 Leader Ready to Use Mineral Oil 118 g/118mL Details

Leader Ready to Use Mineral Oil 118 g/118mL

Product Information

Package

Package Images

NDC 70000-0109-01 (70000010901)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL b8494d02-8a7d-47b4-80b0-b8ab51b625fd Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 118 mL delivered dose)

Purpose

Uses

Warnings

Ask a doctor before use

Stop use and ask a doctor if

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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