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NDC 70000-0450-01 Leader Glycerin 2 g/1 Details

Leader Glycerin 2 g/1

Leader Glycerin is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. The primary component is GLYCERIN.

Product Information

NDC	70000-0450
Product ID	70000-0450_d5fb37b7-7327-fc0f-e053-2995a90af847
Associated GPIs	46600010005215
GCN Sequence Number	002982
GCN Sequence Number Description	glycerin SUPP.RECT ADULT RECTAL
HIC3	Q3S
HIC3 Description	LAXATIVES, LOCAL/RECTAL
GCN	08860
HICL Sequence Number	001312
HICL Sequence Number Description	GLYCERIN
Brand/Generic	Generic
Proprietary Name	Leader Glycerin
Proprietary Name Suffix	Laxative
Non-Proprietary Name	Glycerin
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	2
Active Ingredient Units	g/1
Substance Name	GLYCERIN
Labeler Name	Cardinal Health, 110 dba LEADER
Pharmaceutical Class	Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70000-0450-01 (70000045001)

Pricing Information	N/A
NDC Package Code	70000-0450-1
Billing NDC	70000045001
Package	25 SUPPOSITORY in 1 JAR (70000-0450-1)
Marketing Start Date	2019-01-11
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c76726b1-a162-41c7-9a6a-c69b0db6dc2b Details

Active Ingredient

Active Ingredient Purpose

(in each suppository)

Glycerin, USP 2 grams ............................................Laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 1/4 to 1 hour

Warnings

For rectal use only

Do not use

Do not use laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

- abdominal pain - nausea - vomiting - noticed a sudden change in bowel habits that lasts over 2 weeks

When using this product

When using this product you may have rectal discomfort or a burning sensation

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after use of a laxative

These could be signs of a serious condition.

If pregnant or breast-feeding,

If pregnant or breast-feeding, 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.

Directions

adults and children 6 years and over 1 suppository per day or as directed by doctor

children 2 to under 6 years use CVS/pharmacy(TM) Child Suppositories

children under 2 years ask a doctor

insert 1 suppository well up into the rectum and retain fo 15 minutes

it need not melt to produce laxative action

Other information

keep tightly closed - avoid excessive heat

Inactive ingredients

purified water, sodium hydroxide, stearic acid

Product Label

INGREDIENTS AND APPEARANCE

LEADER GLYCERIN LAXATIVE

glycerin suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0450
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 g

Ingredient Name	Strength
Inactive Ingredients
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white (CLEAR)	Score
Shape	BULLET	Size	32mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0450-1	25 in 1 JAR; Type 0: Not a Combination Product	01/11/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/18/2014

Labeler - Cardinal Health, 110 dba LEADER (063997360)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack, Inc.		009248480	manufacture(70000-0450)

Revised: 1/2022

Document Id: d5fb37b7-7327-fc0f-e053-2995a90af847

Set id: c76726b1-a162-41c7-9a6a-c69b0db6dc2b

Version: 6

Effective Time: 20220119