ACOLYE Lidocaine Cream Topical Analgesia Cream

Manufacturer
Guangdong Aimu Biological Technology Co., Ltd
Effective date
2026-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:33:26

Label at a glance#

ProductACOLYE Lidocaine Cream Topical Analgesia Cream
Active ingredientLIDOCAINE, MENTHOL
Label structure11 sections

Indications and uses

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. For the temporary relief of itching associated with fever blisters and cold sores.

Dosage and administration

Adults and children 12 years of age and older: - Clean affected area with mild soap and warm water, if needed. - Apply a thin layer to the affected area not more than 3 to 4 times daily. - Gently massage until absorbed. If pregnant or breast-feeding, ask a health professional before use. Children under 12 years of age: Do not use. Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE 4%
MENTHOL 1%

Purpose

OTC - PURPOSE SECTION

Topical analgesia

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

For the temporary relief of itching associated with fever blisters and cold sores.

Warnings

WARNINGS SECTION

For external use only.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

If condition worsens, 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.

Do Not Use

OTC - DO NOT USE SECTION

- on wounds or damaged skin.
- on large areas of the body.
- longer than 1 week unless directed by a doctor.

-Do not use in large quantities, particularly over raw surfaces or blistered areas.

When using this product

OTC - WHEN USING SECTION

- Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
- Do not use with heating pads or heat lamps.
- Discontinue use if skin irritation develops.

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

Adults and children 12 years of age and older:
- Clean affected area with mild soap and warm water, if needed.
- Apply a thin layer to the affected area not more than 3 to 4 times daily.
- Gently massage until absorbed.

If pregnant or breast-feeding, ask a health professional before use.
Children under 12 years of age: Do not use. Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea Butter) ,Cocos Nucifera (Coconut) Oil,Macadamia Ternifolia Seed Oil ,Cera Alba,Simmondsia Chinensis (Jojoba) Seed Oil,Prunus Amygdalus Dulcis (Sweet Almond) Oil,Tocopheryl Acetate,Ceramide 2,Bisabolol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130762736709168GTIN-13: 0762736709168
EAN-13: 0762736709168
GTIN-12: 762736709168
UPC-A: 762736709168
GTIN storage (14 digits): 00762736709168
00.jpg

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
83566-61783566-617-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 Lidocaine Cream Topical Analgesia CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd57deebf7-52f1-4256-e063-6294a90a75d52026-07-30WarningsExact identifier
ndc (package): 83566-617-01
ndc (product): 83566-617
ndc11 (package): 83566061701
spl id: 57deebf7-52f2-4256-e063-6294a90a75d5
spl set id: 57deebf7-52f1-4256-e063-6294a90a75d5

Reported adverse events (FAERS/openFDA)#

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