Hemorrhoidal Relief Cream

Manufacturer
CVS Pharmacy, Inc | Melaleuca, Inc.
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:08

Label at a glance#

ProductHemorrhoidal Relief Cream
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure12 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders and temporarily shrinks hemorrhoidal tissue.

WARNINGS SECTION

Warnings

For External use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: when practical, cleanse the affected area with mild soap and warm water. Rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
  • Children under 12 years of age: consult a doctor.

INFORMATION FOR PATIENTS SECTION

Other information

  • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
  • Tamper-Evident: do not use if foil seal under cap is broken or missing.
  • See crimp of tube for lot number and expiration date.

INACTIVE INGREDIENT SECTION

Inactive ingredients:  Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                              Purpose
Lidocaine 5%...............................Local anesthetic
Phenylephrine HCI.........................Vasoconstrictor

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.

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

Rectal bleeding occurs
Condition worsens or does not improve within 7 days
Allergic reaction occurs
Symptoms clear up and return within a few days
Redness, irritation, swelling, pain or other symptoms begin or increase

OTC - ASK DOCTOR/PHARMACIST SECTION

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


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

OTC - WHEN USING SECTION

When using this product

Do not put this product into the rectum by using fingers or any mechanical device or applicator
Do not exceed the recommended daily dosage unless directed by a doct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1314136lidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN1
1314136lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1
1314136lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-984-012022-01-28C16284748780-1d6a99b39-dd39-a426-e053-dadaa90af4c2CVS Health Maximum Strength Hemorrhoidal Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-984-01Hemorrhoidal Relief Cream1 in 1 BOXCREAM11
69842-984-02Hemorrhoidal Relief Cream28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-984HEMORRHOIDAL RELIEF CREAM (LIDOCANE AND PHENYLEPHRINE HCL) CREAM [CVS PHARMACY, INC]1Legacy NDC, 2 package rows20200626_a8f123de-2a73-5bbc-e053-2a95a90a9ddc.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-98469842-984-02, 69842-984-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
a8f10a3c-2231-2872-e053-2a95a90aab75a8f123de-2a73-5bbc-e053-2a95a90a9ddc2020-06-25WarningsExact identifier
spl id: a8f10a3c-2231-2872-e053-2a95a90aab75
spl set id: a8f123de-2a73-5bbc-e053-2a95a90a9ddc

Reported adverse events (FAERS/openFDA)#

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