Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream

Manufacturer
Guangzhou Haishi Biological Technology Co., Ltd.
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:38:19

Label at a glance#

ProductAcolye Numbing Cream Anorectal(Hemorrhoidal) Cream
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE 5%

Purpose

OTC - PURPOSE SECTION

For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Stop Use

OTC - STOP USE SECTION

Stop using and ask a doctor if:
Condition worsens or does not improve within 7 days.
An allergic reaction occurs to ingredients in this product.
The symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Symptoms clear up and return within a few days.
Keep out of reach of children.
If swallowed, get medical help.
If pregnant or breastfeeding, ask a health professional before use.

Do Not Use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When Using

OTC - WHEN USING SECTION

When using this product:
Do not get into the eyes.
Do not exceed recommended dosage unless directed by a doctor.
Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Keep Out Of Reach Of Children

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 immediately.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water: 82%
Arnica: 2%
Emu oil: 2%
Lecithin (Soybean): 2%
Propylene Glycol: 2%
Tocopheryl Acetate: 2%
Carbomer 934: 2%
Benzyl Alcohol: 1%

Dosage & administration

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: Apply externally to the affected area. APPLY UP TO 6 TIMES DAILY.
Children under 12 years of age: Consult a doctor.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.Label.

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130762736709038GTIN-13: 0762736709038
EAN-13: 0762736709038
GTIN-12: 762736709038
UPC-A: 762736709038
GTIN storage (14 digits): 00762736709038
00(1).jpg

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
60771-0029-1Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream60 g in 1 JARCREAM601

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60771-002960771-0029-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b452a3-76b7-2433-e063-6294a90ab6b42025-10-09WarningsExact identifier
ndc (package): 60771-0029-1
ndc (product): 60771-0029
ndc11 (package): 60771002901
spl id: 40b452a3-76b8-2433-e063-6294a90ab6b4
spl set id: 40b452a3-76b7-2433-e063-6294a90ab6b4

Reported adverse events (FAERS/openFDA)#

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