Hemorrhoidal-Ointment

Manufacturer
Rrhoid Rage
Effective date
2022-06-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:48

Label at a glance#

ProductHemorrhoidal-Ointment
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%..................................................Local Anesthetic

Phenylephrine Hydrochloride 0.25%...............Vasoconstrictor

OTC - PURPOSE SECTION

Local anesthetic, Vasoconstrictor

INDICATIONS & USAGE SECTION

-Helps relieve the pain, itching, and burning associated with hemorrhoids.

-Temporarily reduces the swelling associated with irritated hemorrhoidal
tissue and other anorectal disorders.
-Temporarily provides a coating for relief of anorectal discomforts.
-Temporarily protects irritated areas and inflamed perianal skin.

WARNINGS SECTION

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
-Avoid contact with eyes.
-Do not exceed recommended daily dosage unless directed by a doctor.
-Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if
-Bleeding occurs.
-Condition worsens or does not improve within 7 days.
-Allergic reaction occurs to ingredients in this product.
-Symptom being treated does not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase.

If pregnant or breastfeeding, ask a doctor 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.

DOSAGE & ADMINISTRATION SECTION

-When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
-Adults and children 12 years and older: apply externally to the affected area up to 4 times daily.
-Children under 12 years of age: consult a doctor.

Other information
-Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F).

INACTIVE INGREDIENT SECTION

aloe extract AQ, balsam fir, butylated hydroxyanisol, glycerin, lanolin alcohols, lanolin USP,
magnesium sulfate, methyl paraben, mineral oil, petrolatum, propylparaben, witch hazel, white
bees wax.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tubetube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentPSN1
2673304lidocaine 0.04 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD1
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82433-101-012024-01-30C16284748780-11030e365-0a17-111a-e063-dadaa90a10e2Rrhoid Rage hemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82433-101-01Hemorrhoidal-Ointment28 g in 1 TUBEOINTMENT281
82433-101-01Hemorrhoidal-Ointment1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82433-101HEMORRHOIDAL-OINTMENT (LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25) OINTMENT [RRHOID RAGE]1Legacy NDC, 2 package rows20220607_e0cb37bd-6dc9-de9c-e053-2a95a90a3516.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82433-10182433-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e0cb37bd-6dca-de9c-e053-2a95a90a3516e0cb37bd-6dc9-de9c-e053-2a95a90a35162022-06-06WarningsExact identifier
spl id: e0cb37bd-6dca-de9c-e053-2a95a90a3516
spl set id: e0cb37bd-6dc9-de9c-e053-2a95a90a3516

Reported adverse events (FAERS/openFDA)#

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