85248-052update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-22 05:10:08

Label at a glance#

ProductSubleef NUMBING
Active ingredientLIDOCAINE
Label structure13 sections

Dosage and administration

Adults and children 2 years of age and older.Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: Do not use, consult a doctor

Storage and handling

Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

·For external use only. ·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

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

When Using

OTC - WHEN USING SECTION

·Avoid contact with eyes, lf this happens, rinse thoroughly with water.

Stop Use

OTC - STOP USE SECTION

·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptom being treated does not subside or if redness, irritation

Ask Doctor

OTC - ASK DOCTOR SECTION

·Condition worsens or does not improve within 7 days.·Allergic reaction occurs to ingredients in this product.·Symptom being treated does not subside or if redness, irritation

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older.Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: Do not use, consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-05285248-052-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-05full-release2026-06-01 01:37:37

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
Subleef NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a201a6b-adde-c0a8-e063-6394a90a82852026-07-20WarningsExact identifier
ndc (package): 85248-052-01
ndc (product): 85248-052
ndc11 (package): 85248005201
spl id: 5708e469-be5a-3824-e063-6294a90a6ba2
spl set id: 4a201a6b-adde-c0a8-e063-6394a90a8285

Reported adverse events (FAERS/openFDA)#

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