FDA.reportPublic FDA data

Hemorrhoidal Relief Cream

Manufacturer
Shield Line LLC
Effective date
2021-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:46

Label at a glance#

ProductHemorrhoidal Relief Cream
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, LIDOCAINE
Label structure2 sections

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine USP 4%

Phenylephrine HCL USP 0.25%

Purpose

OTC - PURPOSE SECTION

Lidocaine USP 4%--------------Local Anesthetic

Phenylephrine HCL USP 0.25%--Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
  • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

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
  • difficulty in urination due to enlargement of the 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 recommended daily usage 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:

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • if symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
  • to use dispensing cap, attach it to the tube, lubricate well, then gentle insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly
  • apply to affected area upto 4 times daily, especially at night, when waking up and after each bowel movement

Children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 59 to 77 F to avoid melting

Inactive ingredients

INACTIVE INGREDIENT SECTION

.Alpha.-Tocopherol Acetate, Aloe Vera Leaf, Asian Ginseng, Calendula officinalis Flower, Chamomile, Chlorocresol, Cholecalciferol, Coconut Oil, Corn Oil, Dimethicone, Fragrance, Hyaluronate Sodium, Hydrocortisone, Lysine Hydrochloride, menthol, Mineral Oil, Petrolatum, Propylene Glycol, Pyridoxine Hydrochloride, Sunflower Oil, Tricaprilin, Vitamin A Palmitate, yellow Wax, Zinc Oxide

Principal Display & Drug Fact Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Fact PanelDrug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2529640lidocaine 4 % / phenylephrine hydrochloride 0.25 % Rectal CreamPSN1
2529640lidocaine 40 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1
2529640lidocaine 4 % / 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
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9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
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59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
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26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
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da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52410-3077-52023-01-30C16284748780-1f386c649-dfa1-0266-e053-dadaa90a7c1aHemorrhoidal Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-3077-5Hemorrhoidal Relief Cream28.3 g in 1 TUBECREAM28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-3077HEMORRHOIDAL RELIEF CREAM (LIDOCAINE) CREAM [SHIELD LINE LLC]1Legacy NDC, 1 package rows20210305_bcb982e7-e099-2282-e053-2a95a90addbe.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52410-307752410-3077-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ASIAN GINSENGCUQ3A77YXIIACT
CHAMOMILEFGL3685T2XIACT
CHLOROCRESOL36W53O7109IACT
CHOLECALCIFEROL1C6V77QF41IACT
CORN OIL8470G57WFMIACT
DIMETHICONE92RU3N3Y1OIACT
HYALURONATE SODIUMYSE9PPT4THIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
YELLOW WAX2ZA36H0S2VIACT
LIDOCAINE98PI200987ACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COCONUT OILQ9L0O73W7LIACT
HYDROCORTISONEWI4X0X7BPJIACT
ZINC OXIDESOI2LOH54ZIACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
TRICAPRILIN6P92858988IACT
MENTHOLL7T10EIP3AIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
SUNFLOWER OIL3W1JG795YIIACT

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
bcb982e7-e09a-2282-e053-2a95a90addbebcb982e7-e099-2282-e053-2a95a90addbe2021-03-04WarningsExact identifier
spl id: bcb982e7-e09a-2282-e053-2a95a90addbe
spl set id: bcb982e7-e099-2282-e053-2a95a90addbe

Reported adverse events (FAERS/openFDA)#

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