FDA.reportPublic FDA data

85248-046update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-06-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-17 05:10:10

Label at a glance#

ProductNieapf NUMBING
Active ingredientLIDOCAINE
Label structure13 sections

Dosage and administration

·Cleanse targeted skin area, pat dry. ·Apply a thin layer to the affected area, not more than 3-4 times daily.

Storage and handling

Store at 15-30°C(59-86°F)·Protect from excessive heat and direct sunlight-· Use only as directed

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% （w/w）

Purpose

OTC - PURPOSE SECTION

External analgesic

Use

INDICATIONS & USAGE SECTION

·Temporarily relieves pain and itching due to: minor burns,sunburn, insect bites, scrapes, minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

·on large areas of the body.·on broken, blistered, or abraded skin. · if allergic to local anesthetics such as lidocaine, benzocaine, or other "caine" derivatives

When Using

OTC - WHEN USING SECTION

·avoid contact with the eyes - ·do not bandage tightly or use with heating pad -· use only as directed

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,iritation

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,iritation

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

·Cleanse targeted skin area, pat dry. ·Apply a thin layer to the affected area, not more than 3-4 times daily.

Other information

STORAGE AND HANDLING SECTION

Store at 15-30°C(59-86°F)·Protect from excessive heat and direct sunlight-· Use only as directed

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
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

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
85248-04685248-046-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LIDOCAINE98PI200987ACTIB
SOYBEAN LECITHIN1DI56QDM62IACT
CARBOMER 934Z135WT9208IACT
BENZYL ALCOHOLLKG8494WBHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-03full-release2026-06-01 01:37:11

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
Nieapf NUMBINGLIDOCAINE 4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e7534f-bccf-4ef4-e063-6294a90aeb7f2026-06-14WarningsExact identifier
ndc (package): 85248-046-01
ndc (product): 85248-046
ndc11 (package): 85248004601
spl id: 54414265-0327-66e8-e063-6294a90a0ebc
spl set id: 49e7534f-bccf-4ef4-e063-6294a90aeb7f

Reported adverse events (FAERS/openFDA)#

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