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NDC 70000-0223-01 Leader Hemorrhoidal 2211; 6.5 mg/1; mg/1 Details

Leader Hemorrhoidal 2211; 6.5 mg/1; mg/1

Leader Hemorrhoidal is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. The primary component is COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE.

Product Information

NDC	70000-0223
Product ID	70000-0223_446e6cb3-0983-4a7f-bf0a-1834cf7cd7ae
Associated GPIs	89994002335225
GCN Sequence Number	071662
GCN Sequence Number Description	phenylephrine HCl/cocoa butter SUPP.RECT 0.25-88.44 RECTAL
HIC3	Q3D
HIC3 Description	HEMORRHOIDAL PREPARATIONS
GCN	35585
HICL Sequence Number	040185
HICL Sequence Number Description	PHENYLEPHRINE HCL/COCOA BUTTER
Brand/Generic	Generic
Proprietary Name	Leader Hemorrhoidal
Proprietary Name Suffix	n/a
Non-Proprietary Name	cocoa butter, phenylephrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	SUPPOSITORY
Route	RECTAL
Active Ingredient Strength	2211; 6.5
Active Ingredient Units	mg/1; mg/1
Substance Name	COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Labeler Name	Cardinal Health 110, LLC. dba Leader
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part346
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0223-01 (70000022301)

Pricing Information
NDC Package Code	70000-0223-1
Billing NDC	70000022301
Package	12 BLISTER PACK in 1 CARTON (70000-0223-1) / 1 SUPPOSITORY in 1 BLISTER PACK
Marketing Start Date	2017-01-17
NDC Exclude Flag	N
Price Per Unit	0.198
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	HEMORRHOIDAL SUPPOSITORIES
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
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 c4814524-0f4c-4351-a431-5b4b6431fd28 Details

Active ingredients (in each suppository)

Cocoa butter 88.44%

Phenylephrine HCl 0.25%

Purposes

Protectant

Vasoconstrictor

Uses

•: helps relieve the local itching and discomfort associated with hemorrhoids
•: temporarily relieves burning and shrinks hemorrhoidal tissue
•: temporarily provides a coating for relief of anorectal discomforts
•: temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For rectal use only

Ask a doctor before use if you have

•: heart disease
•: high blood pressure
•: thyroid disease
•: diabetes
•: difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug for high blood pressure or depression.

When using this product

do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

•: bleeding occurs
•: condition worsens or does not improve within 7 days

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. (1-800-222-1222)

Directions

•: adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
•: detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
•: hold suppository with rounded end up
•: see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
•: slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
•: remove exposed suppository from wrapper
•: insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
•: children under 12 years of age: ask a doctor

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

methylparaben, propylparaben, topical starch

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Hemorrhoidal Suppositories

Reduces Internal Swelling

Soothes and Protects

Prompt Soothing Relief From Painful Burning, Itching and Discomfort

For Nighttime Relief

12 SUPPOSITORIES

COMPARE TO PREPARATION H®

active ingredients

100% Money Back Guarantee

INGREDIENTS AND APPEARANCE

LEADER HEMORRHOIDAL

cocoa butter, phenylephrine hcl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0223
Route of Administration	RECTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR)	COCOA BUTTER	2211 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	6.5 mg

Ingredient Name	Strength
Inactive Ingredients
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	YELLOW (light)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0223-1	12 in 1 CARTON	01/17/2017
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part346	01/17/2017

Labeler - Cardinal Health 110, LLC. dba Leader (063997360)

Revised: 7/2022

Document Id: 446e6cb3-0983-4a7f-bf0a-1834cf7cd7ae

Set id: c4814524-0f4c-4351-a431-5b4b6431fd28

Version: 3

Effective Time: 20220729