Hemorrhoidal

Manufacturer: Kareway Product, Inc.
Effective date: 2012-07-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:37

Label at a glance#

ProductHemorrhoidal

Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE

Label structure8 sections

Indications and 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

Dosage and administration

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 ointment. when first opening tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement intrarectal use: remove cover form applic...

Storage and handling

Other information Store at 20 o to 25 o C (68 o to 77 o F)

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

bleeding occurs
condition worsens or does not improve within 7 days
introduction of applicator into the rectum causes additional pain

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, 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 ointment.
when first opening tube, puncture foil seal with top end of cap
apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
intrarectal use: remove cover form applicator and attach tube, lubricate applicator well, then gently insert applicator into the rectum - thoroughly cleanse applicator after each use and replace cover
also apply ointment to external area
regular use provides continual therapy for relief of symptoms
children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Other information

Store at 20^o to 25^oC (68^o to 77^oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thyme oil, tocopherols excipient, white wax

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Mineral oil 14%

Petrolatum 71.9%

Phenylephrine HCL 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pure-Aid Hemorrhoidal Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1313818	mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % Rectal Ointment	PSN	1
1313818	mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment	SCD	1
1313818	mineral oil 14 % / petrolatum 71.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67510-0056-1	2019-11-13	C162847	48780-1	97449f38-cb9f-f6ea-e053-dbdaa90aa703	Drug Facts
67510-0056-2	2019-11-13	C162847	48780-1	97449f38-cb9f-f6ea-e053-dbdaa90aa703	Drug Facts
67510-0056-6	2019-11-13	C162847	48780-1	97449f38-cb9f-f6ea-e053-dbdaa90aa703	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67510-0056-1	Hemorrhoidal	28 g in 1 TUBE	OINTMENT	28	1
67510-0056-1	Hemorrhoidal	1 in 1 CARTON	OINTMENT	1	1
67510-0056-2	Hemorrhoidal	57 g in 1 TUBE	OINTMENT	57	1
67510-0056-2	Hemorrhoidal	1 in 1 CARTON	OINTMENT	1	1
67510-0056-6	Hemorrhoidal	1 in 1 CARTON	OINTMENT	1	1
67510-0056-6	Hemorrhoidal	19 g in 1 TUBE	OINTMENT	19	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0056	HEMORRHOIDAL (MINERAL OIL,PETROLATUM,PHENYLEPHRINE) OINTMENT [KAREWAY PRODUCT, INC.]	1	Legacy NDC, 6 package rows	20120725_6d41efab-dede-4846-a23b-53b0eab252b5.zip

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
BENZOIC ACID	INACTIVE INGREDIENT	8SKN0B0MIM	1
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SHARK LIVER OIL	INACTIVE INGREDIENT	4B24275HEU	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	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 · 19 matching rows.

Hemorrhoidal
MINERAL OIL,PETROLATUM,PHENYLEPHRINE
MINERAL OIL
PETROLATUM
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
BENZOIC ACID
BUTYLATED HYDROXYANISOLE
CORN OIL
GLYCERIN
LANOLIN
LANOLIN ALCOHOLS
METHYLPARABEN
PARAFFIN
PROPYLPARABEN
WATER
SHARK LIVER OIL
THYME OIL
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0056	67510-0056-2, 67510-0056-1, 67510-0056-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MINERAL OIL	T5L8T28FGP	ACTIB
PETROLATUM	4T6H12BN9U	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
BENZOIC ACID	8SKN0B0MIM	IACT
BUTYLATED HYDROXYANISOLE	REK4960K2U	IACT
CORN OIL	8470G57WFM	IACT
GLYCERIN	PDC6A3C0OX	IACT
LANOLIN	7EV65EAW6H	IACT
LANOLIN ALCOHOLS	884C3FA9HE	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SHARK LIVER OIL	4B24275HEU	IACT
THYME OIL	2UK410MY6B	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 6 · 349 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, FILM COATED / ORAL	1.55 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	SUSPENSION / RECTAL	0.1 %w/w		Exact identifier — unii candidate 23 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	OINTMENT / VAGINAL	0.02 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	FILM / SUBLINGUAL	0.08 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 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
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	CAPSULE, LIQUID FILLED / ORAL		4 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	CAPSULE / ORAL		4 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	SUSPENSION / TOPICAL		11726 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY, METERED / NASAL		13 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE / DENTAL	20 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	CREAM / VAGINAL		10 mg	Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PARAFFIN	PARAFFIN	I9O0E3H2ZE	TABLET, EXTENDED RELEASE / ORAL		321 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 23 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
LANOLIN ALCOHOLS	LANOLIN ALCOHOLS	884C3FA9HE	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BENZOIC ACID	BENZOIC ACID	8SKN0B0MIM	LIQUID / ORAL	2 mg/1ml		Exact identifier — unii candidate 23 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	OINTMENT / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 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	CREAM / TOPICAL		3000 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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / SUBCUTANEOUS	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLATED HYDROXYANISOLE	BUTYLATED HYDROXYANISOLE	REK4960K2U	LOTION / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
LANOLIN ALCOHOLS	LANOLIN ALCOHOLS	884C3FA9HE	OINTMENT / TOPICAL		452 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 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
34a8ecee-2848-4827-9b4e-910a7aaed43d			6d41efab-dede-4846-a23b-53b0eab252b5	2012-07-02	Warnings	Exact identifier spl id: 34a8ecee-2848-4827-9b4e-910a7aaed43d spl set id: 6d41efab-dede-4846-a23b-53b0eab252b5

Reported adverse events (FAERS/openFDA)#

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