LEADER HEMORRHOIDAL

Manufacturer: CARDINAL HEALTH, INC. | G&W Laboratories, Inc.
Effective date: 2012-01-30
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:47:55

Label at a glance#

ProductLEADER HEMORRHOIDAL

Active ingredientPhenylephrine Hydrochloride, Fat, Hard

Label structure10 sections

Indications and 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

Dosage and administration

Storage and handling

• store at 20-25˚C (68-77˚F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Hard Fat 85.5%
Phenylephrine HCl 0.25%

PURPOSE

OTC - PURPOSE SECTION

● Protectant
● Vasoconstrictor

USES

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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 an enlarged prostate

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 use more than directed

Stop use and ask a doctor if
• symptoms get worse or do not get better in 7 days
• bleeding occurs

IF PREGNANT OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or a soft cloth before insertion of the product.
• detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:

                  Removal of Wrapper Diagram
                  • hold suppository with pointed end up
                  • carefully separate tabs with fingernail
                  • slowly pull apart by pulling tabs down on both sides
                  • remove 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: ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• store at 20-25˚C (68-77˚F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

cod liver oil, corn starch, methylparaben, propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 37205-715-16

Compare to Preparation H® active ingredients

LEADER HEMORRHOIDAL SUPPOSITORIES
Prompt Relief
For Temporary Relief From Pain and Itching of Hemorrhoids
12 ADULT SUPPOSITORIES

Satisfaction Guaranteed

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
37205-715-16	2025-04-24	C162847	48780-1	9d75b9d0-c32b-f424-e053-dadaa90a57ce	Hemorrhoidal Suppositories
37205-715-16	2020-01-31	C162847	48780-1	9d75b9d0-c32b-f424-e053-dadaa90a57ce	Hemorrhoidal Suppositories

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-715-16	EA - Each	37205-715	700bf1af-35eb-4d01-bf7a-052fbdf28b38	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Fat, Hard	ACTIVE INGREDIENT	8334LX7S21	3
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	3
Fat, Hard	ACTIVE MOIETY	8334LX7S21	3
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	3
Cod Liver Oil	INACTIVE INGREDIENT	BBL281NWFG	3
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	3
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	3
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

LEADER HEMORRHOIDAL
Phenylephrine Hydrochloride, Hard Fat
Phenylephrine Hydrochloride
Phenylephrine
Fat, Hard
Cod Liver Oil
Starch, Corn
Methylparaben
Propylparaben

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-715	37205-715-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Phenylephrine Hydrochloride	04JA59TNSJ	ACTIB
Fat, Hard	8334LX7S21	ACTIB
Cod Liver Oil	BBL281NWFG	IACT
Starch, Corn	O8232NY3SJ	IACT
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 169 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	SUSPENSION, EXTENDED RELEASE / ORAL		113 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / RECTAL		271 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / TOPICAL		420 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Starch, Corn	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a1c3daa5-cf02-4ab6-9ed2-f98391974d9f			923f8ca3-7488-eb2d-d745-1e5dd79a7bc6	2025-04-18	Warnings	Exact identifier spl set id: 923f8ca3-7488-eb2d-d745-1e5dd79a7bc6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.