FDA.reportPublic FDA data

HEMPORRHOID CREAM

Manufacturer
Renu Laboratories, Inc.
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:01

Label at a glance#

ProductHemporrhoid
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

For the temporary relief of Pain Itching Burning associated with inflamed hemorrhoidal tissues

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Hemorrhoidal Cream

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 5%

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of

  • Pain
  • Itching
  • Burning associated with inflamed hemorrhoidal tissues

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • Keep out of eyes. Rinse with water to remove. Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - STOP USE SECTION

Stop use and ask a doctor if conditions worsen, or, if symptoms persist for more than 7 days, or clear up and occur again within a few days. Discontinue use of this product and consult a doctor.

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 - PREGNANCY OR BREAST FEEDING SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily.

Children under 2 years of age: Consult a doctor.

OTHER SAFETY INFORMATION

Other information: Store between 58 - 87° F

Protect from freezing, direct heat or sunlight.

INACTIVE INGREDIENT SECTION

INGREDIENTS: Capryl Glycol, Caprylic / Capric Triglyceride, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin, Hemp Extract with proprietary Terpene blend: (Beta Caryophyllene, Humulene, Limonene, Myrcene, Linalool, Nerolidol, Beta Pinene, Alpha Pinene, Eucalyptol), Hexylene Glycol, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEMPORRHOID TUBE ART

Hemporrhoid 1.0 oz. tube artHemporrhoid 1.0 oz. tube art

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-590-022024-01-30C16284748780-11030e365-05d4-111a-e063-dadaa90a10e2HEMPORRHOID CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-590-01Hemporrhoid28 g in 1 TUBECREAM284
76348-590-02Hemporrhoid1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-590HEMPORRHOID (LIDOCAINE HCL) CREAM [RENU LABORATORIES, INC.]4Legacy NDC, 2 package rows20220115_b4df1e62-2585-fff7-e053-2a95a90aca06.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-59076348-590-01, 76348-590-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARYOPHYLLENEBHW853AU9HIACT
.BETA.-PINENE4MS8VHZ1HJIACT
STEARIC ACID4ELV7Z65APIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WHITE WAX7G1J5DA97FIACT
HUMULENE54W56MD2WDIACT
MYRCENE3M39CZS25BIACT
LINALOOL, (+)-F4VNO44C09IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
EDETATE SODIUMMP1J8420LUIACT
CANNABIDIOL19GBJ60SN5IACT
EUCALYPTOLRV6J6604TKIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
.ALPHA.-PINENEJPF3YI7O34IACT
NEROLIDOLQR6IP857S6IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
TOCOPHEROLR0ZB2556P8IACT
LIMONENE, (+)-GFD7C86Q1WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
JOJOBA OIL724GKU717MIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT

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
d58ff524-01c9-7574-e053-2995a90a7c52b4df1e62-2585-fff7-e053-2a95a90aca062022-01-14WarningsExact identifier
spl id: d58ff524-01c9-7574-e053-2995a90a7c52
spl set id: b4df1e62-2585-fff7-e053-2a95a90aca06

Reported adverse events (FAERS/openFDA)#

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