FDA.reportPublic FDA data

Anecream 5

Manufacturer
Focus Health Group
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:53:39

Label at a glance#

ProductAnecream 5
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

temporarily relieves pain and itching due to anorectal disorders

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting of blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: Apply to the affected area up to 6 times a day. Children under 12 years of age: Consult a doctor.

Storage and handling

Store at USP controlled room temperature 20-25C (66-77F).

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION


Local anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to anorectal disorders

Warnings

WARNINGS SECTION

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor

Stop and ask a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting of blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: 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

Store at USP controlled room temperature 20-25C (66-77F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

Anecream5 15g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anecream 5 15gAnecream 5 15g

AC 5art 15gm.jpg

The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

Anecream5 Anorectal Cream

Net. Wt. 15g

Distributed by: Focus Health Group

Knoxville, TN 37919

Anecream5 15g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1422078AneCream5 5 % Rectal CreamPSN14
1366789lidocaine 5 % Rectal CreamPSN14
1422078lidocaine 50 MG/ML Rectal Cream [AneCream]SBD14
1366789lidocaine 50 MG/ML Rectal CreamSCD14
1422078AneCream (lidocaine 5 % ) Rectal CreamSY14
1422078AneCream 5 % Rectal CreamSY14
1422078AneCream 50 MG/ML Rectal CreamSY14
1422078AneCream5 Rectal CreamSY14
1366789lidocaine 5 % Rectal CreamSY14

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
24357-702-15Anecream 515 g in 1 TUBECREAM1514
24357-702-15Anecream 51 in 1 CARTONCREAM114
24357-702-30Anecream 51 in 1 CARTONCREAM114
24357-702-30Anecream 530 g in 1 TUBECREAM3014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24357-702ANECREAM 5 (LIDOCAINE 5%) CREAM [FOCUS HEALTH GROUP]14Current NDC, Legacy NDC, 4 package rows20250126_1810edc3-093e-402f-bcb0-9c731da283a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24357-702-15GM - Gram24357-7024c87b13c-5d18-43ac-a51e-c007c712ccc812012-07-24
24357-702-30GM - Gram24357-702a9e827a9-a339-4bd0-a793-81ff45a3e0fa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009871
LIDOCAINEACTIVE MOIETY98PI2009871

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24357-70224357-702-15, 24357-702-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
CHOLESTEROL97C5T2UQ7JIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
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
Anecream 5LIDOCAINE 5%Focus Health Group1810edc3-093e-402f-bcb0-9c731da283a72025-01-15WarningsExact identifier
ndc (package): 24357-702-15
ndc (package): 24357-702-30
ndc (product): 24357-702
ndc11 (package): 24357070215
ndc11 (package): 24357070230
spl id: 2bc3f0b3-7597-34d5-e063-6294a90af4a1
spl set id: 1810edc3-093e-402f-bcb0-9c731da283a7

Reported adverse events (FAERS/openFDA)#

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