FDA.reportPublic FDA data

Local Anesthetic Anorectal Cream

Manufacturer
Make Labs LLC
Effective date
2024-09-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:55

Label at a glance#

ProductLocal Anesthetic Anorectal Cream
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients purpose

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

OTC - PURPOSE SECTION

Uses

Temporary relief of pain, itching, and discomfort associated with hemorrhoids

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

WARNINGS SECTION

Warnings

For external use only

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults: When practical, clean affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Apply externally to the affected area up to 6 times a day.
  • Children 12 and under, consult a physician prior to use.

INACTIVE INGREDIENT SECTION

Inactive ingredients Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butyrospermum Parkii (Shea) Butter, Benzyl Alcohol, Cetearyl Alcohol, Ceteth-20, Carbomer, Cholesterol, Ethoxydiglycol, Lecithin, PPG-12/SMDI Copolymer, Propanediol, Polysorbate 60, Simmondsia Chinensis (Jojoba) Seed Oil, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

numbing.com

Local Anesthetic

Anorectal Cream

Net Wt. 6 OZ / 170g

Tube numbing creamTube numbing cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN1
1366789lidocaine 50 MG/ML Rectal CreamSCD1
1366789lidocaine 5 % Rectal CreamSY1

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84767-001-01Local Anesthetic Anorectal Cream170 g in 1 TUBECREAM1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84767-001LOCAL ANESTHETIC ANORECTAL CREAM (LIDOCAINE) CREAM [MAKE LABS LLC]11 package rows20240922_22685fd6-d236-3495-e063-6394a90ac18a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84767-00184767-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
CHOLESTEROL97C5T2UQ7JIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
BENZYL ALCOHOLLKG8494WBHIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
PROPANEDIOL5965N8W85TIACT
POLYSORBATE 60CAL22UVI4MIACT
JOJOBA OIL724GKU717MIACT
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
22685fd6-d237-3495-e063-6394a90ac18a22685fd6-d236-3495-e063-6394a90ac18a2024-09-18WarningsExact identifier
spl id: 22685fd6-d237-3495-e063-6394a90ac18a
spl set id: 22685fd6-d236-3495-e063-6394a90ac18a

Reported adverse events (FAERS/openFDA)#

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