Subleef NUMBING — v1

Subleef NUMBING

4 Views

Version

v1

Effective date

September 19, 2025

Original packager

Yes

Sections captured

14

Identifiers

Document ID
3f24bb25-7a1d-5782-e063-6294a90aff29
Set ID
3f24bb25-7a1c-5782-e063-6294a90aff29
Application numbers
M017
Product NDCs
84010-186
Package NDCs
84010-186-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Subleef NUMBING
Generic names
LIDOCAINE4% NUMBING
Manufacturer names
Jiangxi Hemei Pharmaceutical Co., Ltd
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
LIDOCAINE
Routes
TOPICAL
Pharmacologic class (PE)
Local Anesthesia [PE]
Pharmacologic class (EPC)
Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
Pharmacologic class (CS)
Amides [CS]
Mechanism of action
—

Other identifiers

NUI
M0000897, N0000175426, N0000175682, N0000175976
RxCUI
1421893
UNII
98PI200987
UPC
6974603691399

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredient Lidocaine 4%
Ask Doctor (1)

Sequence 1

Ask Doctor ■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. ■Stop use and sek meditcal attention if signs of an alergy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.
Disposal And Waste Handling (1)

Sequence 1

Other information Store between 15-30℃(59-86F). Avoid freezing and excessive heat above 40 ℃(104°F).
Do Not Use (1)

Sequence 1

Do not use ■In children under 2 years of on irritated or sensitive skin. ■Do not exceed the recommended daily dosage unless directed by a doctor.
Dosage And Administration (1)

Sequence 1

Directions ■Before applying the numbing cream,make sure to wash your hands thoroughly and put on disposable procedure gloves. ■Clean the area of the body receivina the procedure,Dry completely. ■Apply a generous amount of numbing cream to the cleaned area and rub it in thoroughly in a circlar motion for 30 to 60 seconds,Then. cover with plastic wrap. ■ Leave the cream and wrap in place for 30 to 45 minutes,Wipe away the cream and thoroughly clean the area to prepare for the upcoming procedure.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Water,Carbomer934, propylene Glycol,soybean Lecithin,.Alpha.-Tocopherol Acetate,Benzyl Alcohol.
Indications And Usage (1)

Sequence 1

Use For temporary relief of local discomfort, itching, pain, soreness, or burning associated with minor skin procedure.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep Oot Of Reach Of Children Keep out of reach of children
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL 4
Purpose (1)

Sequence 1

Purpose Local Anesthetic
Spl Product Data Elements (1)

Sequence 1

Subleef NUMBING Lidocaine4% NUMBING SOYBEAN LECITHIN WATER CARBOMER 934 BENZYL ALCOHOL LIDOCAINE LIDOCAINE PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE
Stop Use (1)

Sequence 1

Stop Use ■If symptoms persist for more than 7 days or subside but occur again within 3 days, stop use and consult a physician. ■Stop use and sek meditcal attention if signs of an alergy occur,such as rednes,irtation,sweling, pain, or other severe symptoms.If symptoms do not subside completely within 7 days, seek medical help.
Warnings (1)

Sequence 1

Warnings ■For external use only.
When Using (1)

Sequence 1

When Using ■Avoid contact with eyes, lf this happens, rinse thoroughly with water.

OpenFDA raw payload

{'application_number': ['M017'],
 'brand_name': ['Subleef NUMBING'],
 'generic_name': ['LIDOCAINE4% NUMBING'],
 'is_original_packager': [True],
 'manufacturer_name': ['Jiangxi Hemei Pharmaceutical Co., Ltd'],
 'nui': ['N0000175682', 'M0000897', 'N0000175426', 'N0000175976'],
 'package_ndc': ['84010-186-01'],
 'pharm_class_cs': ['Amides [CS]'],
 'pharm_class_epc': ['Amide Local Anesthetic [EPC]', 'Antiarrhythmic [EPC]'],
 'pharm_class_pe': ['Local Anesthesia [PE]'],
 'product_ndc': ['84010-186'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'rxcui': ['1421893'],
 'spl_id': ['3f24bb25-7a1d-5782-e063-6294a90aff29'],
 'spl_set_id': ['3f24bb25-7a1c-5782-e063-6294a90aff29'],
 'substance_name': ['LIDOCAINE'],
 'unii': ['98PI200987'],
 'upc': ['6974603691399']}