FDA.reportPublic FDA data

Hemorrhoid Pain Relief

Manufacturer
Telebrands Corp | Neutraderm, Inc.
Effective date
2024-11-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:11

Label at a glance#

ProductHemorrhoid Pain Relief
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For the temporary relief of pain, burning, itching and discomfort associated with hemorrhoids.

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 to affected area. Apply to the affected area up to 6 times a day Children under 12 years of age: consult a doctor.

Storage and handling

Do not use if seal is broken or missing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Lidocaine 5%................Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain, burning, itching and discomfort associated with hemorrhoids.

Warnings

WARNINGS SECTION

For external use only

Allergy alert:If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

OTC - WHEN USING SECTION

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor.
  • use only as directed. Read and follow all directions and warnings on this label.
  • do not put this product into the rectum by using finger or any mechanical device or applicator.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • if condition worsens or does not improve within 7 days
  • in case of bleeding
  • symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Certain persons can develop allergic reactions to ingredients in this product.

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

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 to affected area.
  • Apply to the affected area up to 6 times a day
  • Children under 12 years of age:consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Do not use if seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Ethylhexyl Stearate,Butylene Glycol, Dimethicone, Stearic Acid, Caprylic/Capric Triglyceride,Cannabis Sativa (Hemp) Seed Oil, Glyceryl Stearate, PEG-100 Stearate, CetearylAlcohol, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric)Root Extract, Allantoin, Glycerin, Tocopheryl Acetate, Acrylates/C10-30 AlkylAcrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,Hexylene Glycol, Sodium Hydroxide, Disodium EDTA

Questions?

OTC - QUESTIONS SECTION

Call (855) 877-4503 (M-F, 9am-5pm EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hempvana

NDC 73287-028-01

Maximum OTC Strength

Hemorrhoid Pain Relief

Topical Anesthetic Cream

5% Lidocaine

+ Hemp Seed Oil For Moisturization

Net Wt. 3oz (85g)

100% Fragrance Free

11

22

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
73287-028-01Hemorrhoid Pain Relief85 g in 1 JARCREAM853
73287-028-01Hemorrhoid Pain Relief1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73287-028HEMORRHOID PAIN RELIEF (LIDOCAINE) CREAM [TELEBRANDS CORP]3Current NDC, 2 package rows20241122_04164425-ca3b-ef24-e063-6294a90a59d8.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73287-02873287-028-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEXYLENE GLYCOLKEH0A3F75JIACT
TURMERIC856YO1Z64FIACT
ALLANTOIN344S277G0ZIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
STEARIC ACID4ELV7Z65APIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PEG-100 STEARATEYD01N1999RIACT
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
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
Hemorrhoid Pain ReliefLIDOCAINETelebrands Corp04164425-ca3b-ef24-e063-6294a90a59d82024-11-20WarningsExact identifier
ndc (package): 73287-028-01
ndc (product): 73287-028
ndc11 (package): 73287002801
spl id: 275a333c-1c0c-e9f5-e063-6394a90ae3f5
spl set id: 04164425-ca3b-ef24-e063-6294a90a59d8

Reported adverse events (FAERS/openFDA)#

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