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DG Health Hemorrhoidal

Dolgencorp, LLC Hemorrhoidal Ointment Drug Facts

Approved
Approval ID

d9f12a34-7bd1-4ba5-b34b-1b641f58271a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Dolgencorp, LLC

DUNS: 068331990

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

mineral oil, petrolatum, phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55910-188
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
mineral oil, petrolatum, phenylephrine HCl
Product Specifications
Route of AdministrationRECTAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (16)

MINERAL OILActive
Quantity: 14 g in 100 g
Code: T5L8T28FGP
Classification: ACTIB
PETROLATUMActive
Quantity: 74.9 g in 100 g
Code: 4T6H12BN9U
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: .25 g in 100 g
Code: 04JA59TNSJ
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
LANOLIN ALCOHOLSInactive
Code: 884C3FA9HE
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
THYME OILInactive
Code: 2UK410MY6B
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/12/2025

Package/Label Principal Display Panel

DG™|health

Compare to the active ingredients of Preparation H® Hemorrhoidal Ointment

Hemorrhoidal Ointment

Prevents Further Irritation

• Prompt, soothing relief from painful burning, itching and discomfort

• Shrinks swollen hemorrhoidal tissue

• Protects irritated tissue

• Relieves internal and external discomfort

NET WT 2 OZ (57 g)

![dghealth-hemorrhoidal-ointment-carton- image.jpg](/dailymed/image.cfm?name=dghealth-hemorrhoidal-ointment-carton- image.jpg&id=892447)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/2/2014

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/2/2014

Active ingredients

Mineral oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/2/2014

Purposes

Protectant

Vasoconstrictor

WARNINGS SECTION

LOINC: 34071-1Updated: 10/17/2024

Warnings

For external and/or intrarectal 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

introduction of applicator into the rectum causes additional pain

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/17/2024

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/2/2014

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 applying ointment.

when first opening the 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 from applicator, attach applicator to tube, lubricate applicator well and 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

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/12/2025

Inactive ingredients

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopheryl acetate, white wax

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DG Health Hemorrhoidal - FDA Drug Approval Details