SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF

Manufacturer
ALPHA PLANTS INC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:09

Label at a glance#

ProductSIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For the temporary relief of itching and discomfort in the perianal area. For the temporary relief of pain, soreness, or burning.

Dosage and administration

Adults:• 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 a soft cloth before application of this product. • Children under 12 years of age: consult a doctor. • Apply to the affected area up to 6 times daily.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5.00 %

Purpose

OTC - PURPOSE SECTION

Anorectal (hemorrhoidal)

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of itching and discomfort in the perianal area.
  • For the temporary relief of pain, soreness, or burning.

Warnings:

WARNINGS SECTION

For external use only.

Do not

OTC - DO NOT USE SECTION

  • Put this product into the rectum by using fingers or any mechanical device or applicator.
  • Exceed the recommended daily dosage unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • If condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.

Discontinue use and consult a doctor if

OTC - ASK DOCTOR SECTION

  • The symptoms being treated does not subside.
  • Redness, irritation, swelling, pain, or other symptoms develop or increase.
  • Certain persions can develop allergic reactions to ingredients in this product.

Allergy alert

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults:• 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 a soft cloth before application of this product.

• Children under 12 years of age: consult a doctor.

• Apply to the affected area up to 6 times daily.

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 20-25°C (68-77°F) and protect from moisture.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Deionized Water, Benzyl Alcohol, Carbomer, Propylene Glycol, SD Alcohol 40-B, Sodium Polyacrylate, Tocopheryl Acetate (Vitamin E).

Questions?

OTC - QUESTIONS SECTION

+1 (205) 624-9177

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN2
1366789lidocaine 50 MG/ML Rectal CreamSCD2
1366789lidocaine 5 % Rectal CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82460-262-00SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEF30 mL in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82460-262SIMPLY VITAL HEMORRHOID AND ANORECTAL RELIEF (LIDOCAINE) CREAM [ALPHA PLANTS INC]2Current NDC, Legacy NDC, 1 package rows20231112_79fa4b89-382f-45fa-a792-90a9fe5bf573.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82460-26282460-262-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEFLIDOCAINEALPHA PLANTS INC79fa4b89-382f-45fa-a792-90a9fe5bf5732023-11-11WarningsExact identifier
ndc (package): 82460-262-00
ndc (product): 82460-262
ndc11 (package): 82460026200
spl id: 09e2e2ce-d887-0711-e063-6294a90a9213
spl set id: 79fa4b89-382f-45fa-a792-90a9fe5bf573

Reported adverse events (FAERS/openFDA)#

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