FDA.reportPublic FDA data

Hemorrhoidal cream Rapid Relief with Lidocaine

Manufacturer
VELOCITY PHARMA LLC
Effective date
2019-06-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:37

Label at a glance#

ProductHemorrhoidal
Active ingredientGLYCERIN, LIDOCAINE
Label structure9 sections

Storage and handling

Other information store at 20–25°C (68–77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Glycerin 14.4%Protectant
Lidocaine 5%Local anesthetic

INDICATIONS & USAGE SECTION

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful

WARNINGS SECTION

Warnings

SPL UNCLASSIFIED SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional 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

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 this cream.
  • apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20–25°C (68–77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe vera gel, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propylene glycol, propylparaben, purified water, stearyl alcohol, white soft paraffin, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

Call 888-309-9030

PRINCIPAL DISPLAY PANEL 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HemacreamHemacream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1866218glycerin 14.4 % / lidocaine 5 % Rectal CreamPSN2
1866218glycerin 144 MG/ML / lidocaine 50 MG/ML Rectal CreamSCD2
1866218glycerin 14.4 % / lidocaine 5 % Rectal CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-403-012021-01-29C16284748780-1ba0f9c33-4590-a910-e053-dadaa90a0b85Hemorrhoidal cream Rapid Relief with Lidocaine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-403-01Hemorrhoidal1 in 1 CARTONCREAM12
76168-403-01Hemorrhoidal30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-403HEMORRHOIDAL (GLYCERIN, LIDOCAINE) CREAM [VELOCITY PHARMA LLC]2Legacy NDC, 2 package rows20190604_874f6f42-2c7e-4ecd-a376-aa4d8cf67669.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
76168-40376168-403-01

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
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXPANTHENOL1O6C93RI7ZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
LAURETH-23N72LMW566GIACT
PETROLATUM4T6H12BN9UIACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE98PI200987ACTIB

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
8a80a5e9-0faa-51fe-e053-2995a90aa4f1874f6f42-2c7e-4ecd-a376-aa4d8cf676692019-06-04WarningsExact identifier
spl id: 8a80a5e9-0faa-51fe-e053-2995a90aa4f1
spl set id: 874f6f42-2c7e-4ecd-a376-aa4d8cf67669

Reported adverse events (FAERS/openFDA)#

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