Active ingredient(s)

Manufacturer
Shantou South Moon Biotechnology Co., Ltd.
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-21 05:10:09

Label at a glance#

ProductNumbing Cream
Active ingredientGLYCERIN, 1,2-HEXANEDIOL, PROPYLENE GLYCOL, HYDROXYACETOPHENONE, MENTHOL
Label structure13 sections

Storage and handling

Store at room temperature (15-30°C/59-86°F). Avoid direct sunlight and excessive heat. Do not use if packaging is damaged or seal is broken.

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Glycerin、Propylene Glycol、Menthol、1,2-Hexanediol、Hydroxyacetophenone

Purpose

OTC - PURPOSE SECTION

Temporarily relieves pain and discomfort.

Use

OTC - WHEN USING SECTION

1. Clean and dry the desired area thoroughly.

2. Apply a thick layer of cream evenly over the area.

3. Cover with plastic wrap.

4. Leave on for 30-60 minutes for optimal effect.

5. Remove excess cream before beginning the procedure

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

In large quantities over raw or blistered skin.

On deep puncture wounds or serious burns.

If allergic to lidocaine or any ingredient in this product.

STOP USE

OTC - STOP USE SECTION

In large quantities over raw or blistered skin.

On deep puncture wounds or serious burns.

If allergic to lidocaine or any ingredient in this product.

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

Have heart disease.

Have liver disease.

Are pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

If swallowed, seek medical help immediately or contact a Poison Control Center.Children under 12 years old should use only under adult supervision or medical advice.

STORAGE AND HANDLING SECTION

Store at room temperature (15-30°C/59-86°F).

Avoid direct sunlight and excessive heat.

Do not use if packaging is damaged or seal is broken.

INACTIVE INGREDIENT SECTION

Water、Mineral Oil、Carbomer、Glyceryl Stearate、Triethanolamine

INDICATIONS & USAGE SECTION

Clean and dry affected area thoroughly.

Apply a thin, even layer of cream to the skin.

Allow absorption before covering or proceeding with procedure.

Reapply only as needed, not exceeding 3-4 applications per day.

DOSAGE & ADMINISTRATION SECTION

Clean and dry affected area thoroughly.

Apply a thin, even layer of cream to the skin.

Allow absorption before covering or proceeding with procedure.

Reapply only as needed, not exceeding 3-4 applications per day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84983-03984983-039-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
56c6d4e5-9d4c-324a-e063-6394a90a9a7c56c6d4e5-9d4b-324a-e063-6394a90a9a7c2026-07-16WarningsExact identifier
spl id: 56c6d4e5-9d4c-324a-e063-6394a90a9a7c
spl set id: 56c6d4e5-9d4b-324a-e063-6394a90a9a7c

Reported adverse events (FAERS/openFDA)#

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