Major Prep Hemorrhoidal

Manufacturer: Major Pharmaceuticals
Effective date: 2016-10-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:22:30

Label at a glance#

ProductMajor Prep Hemorrhoidal

Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE

Label structure14 sections

Storage and handling

Other information store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Mineral oil 14%................................................................Protectant

Petrolatum 74.9%............................................................Protectant

Phenylephrine HCl 0.25%..........................................Vasoconstrictor

OTC - PURPOSE SECTION

Uses

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

WARNINGS SECTION

Warnings For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor of pharmacist before use if you are now taking a prescription drug for high blood pressure or depression

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if

bleeding occurs
condition gets worse or does not get better within 7 days
introduction of the applicator into the rectum causes additional pain

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a physician before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Directions

children under 12 years of age: ask a doctor
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 applying
when first opening tube, remove foil seal
for intrarectal use: remove protective cover from applicator and attach to tube
lubricate applicator well, then gently insert applicator into the rectum
thoroughly clean applicator and replace protective cover after each use
apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
also apply ointment to external area

STORAGE AND HANDLING SECTION

Other information store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, lanolin, methylparaben, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

DOSAGE & ADMINISTRATION SECTION

Distributed By

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-6356-02	2024-11-13	C162847	48780-1	d6a99b39-cfc7-a426-e053-dadaa90af4c2	3db88d5e-525b-40ed-884a-1788cc5627aa
0904-6356-02	2022-01-28	C162847	48780-1	d6a99b39-cfc7-a426-e053-dadaa90af4c2	3db88d5e-525b-40ed-884a-1788cc5627aa

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6356-02	GM - Gram	0904-6356	a34ff049-874c-472c-8c98-98caf6913a16	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

Major Prep Hemorrhoidal
Mineral Oil, Petrolatum, Phenylephrine Hydrochloride
MINERAL OIL
PETROLATUM
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
GLYCERIN
LANOLIN
METHYLPARABEN
PROPYLPARABEN
STEARYL ALCOHOL
THYME OIL
TOCOPHEROL
WATER
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0904-6356	0904-6356-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
THYME OIL	2UK410MY6B	IACT
TOCOPHEROL	R0ZB2556P8	IACT
WATER	059QF0KO0R	IACT
WHITE WAX	7G1J5DA97F	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 5 · 263 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / RECTAL		440 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / TOPICAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	TABLET, EXTENDED RELEASE / ORAL	244 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	POWDER / ORAL	0.11 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	SUPPOSITORY / VAGINAL	8.5 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
TOCOPHEROL	TOCOPHEROL	R0ZB2556P8	CREAM / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		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

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
846b5be7-83f7-43e9-9a25-f7166e2f8d79			3db88d5e-525b-40ed-884a-1788cc5627aa	2024-11-12	Warnings	Exact identifier spl set id: 3db88d5e-525b-40ed-884a-1788cc5627aa

Reported adverse events (FAERS/openFDA)#

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