RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) — v1

RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)

3 Views

Version

v1

Effective date

September 29, 2025

Original packager

Yes

Sections captured

12

Identifiers

Document ID
3ffc57c7-5bf5-cba8-e063-6394a90a322f
Set ID
3ffc57c7-5bf4-cba8-e063-6394a90a322f
Application numbers
M015
Product NDCs
60771-0027
Package NDCs
60771-0027-1
Original packager NDCs
—

Names & Manufacturers

Brand names
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)
Generic names
LIDOCAINE
Manufacturer names
Guangzhou Haishi Biological Technology 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
—
UNII
98PI200987
UPC
0860010320167

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients LIDOCAINE 5%
Do Not Use (1)

Sequence 1

Do Not Use on damaged or broken skin.
Dosage And Administration (1)

Sequence 1

Dosage & administration Squeeze out an appropriate amount of Numbing Cream and spread evenly on skin.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients WATER 65% GLYCERIN 2% BUTYLENE GLYCOL 5% SODIUM HYALURONATE 0.1% SHEABUTTER OIL 2% SIMMONDSIA CHINENSIS SEED OIL 2% TOCOPHEROL 0.5% MENTHOL 2% CENTELLA ASIATICA 0.5% ALOE 0.5%
Indications And Usage (1)

Sequence 1

Uses For adults and children aged 12 and older: When practical, clean the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying. For children under 12: Consult a doctor
Keep Out Of Reach Of Children (1)

Sequence 1

Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

PRINCIPAL DISPLAY PANEL Label.
Purpose (1)

Sequence 1

Purpose For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders
Spl Product Data Elements (1)

Sequence 1

RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream) LIDOCAINE GLYCERIN BUTYLENE GLYCOL SODIUM HYALURONATE TOCOPHEROL SHEA BUTTER LIDOCAINE LIDOCAINE WATER MENTHOL ALOE CENTELLA ASIATICA SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
Stop Use (1)

Sequence 1

Stop Use Stop use and ask a doctor if rash occurs.
Warnings (1)

Sequence 1

Warnings For external use only
When Using (1)

Sequence 1

When Using When using this product keep out of eyes. Rinse with water to remove.

OpenFDA raw payload

{'application_number': ['M015'],
 'brand_name': ['RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)'],
 'generic_name': ['LIDOCAINE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Guangzhou Haishi Biological Technology Co., Ltd.'],
 'nui': ['N0000175682', 'M0000897', 'N0000175426', 'N0000175976'],
 'package_ndc': ['60771-0027-1'],
 'pharm_class_cs': ['Amides [CS]'],
 'pharm_class_epc': ['Amide Local Anesthetic [EPC]', 'Antiarrhythmic [EPC]'],
 'pharm_class_pe': ['Local Anesthesia [PE]'],
 'product_ndc': ['60771-0027'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3ffc57c7-5bf5-cba8-e063-6394a90a322f'],
 'spl_set_id': ['3ffc57c7-5bf4-cba8-e063-6394a90a322f'],
 'substance_name': ['LIDOCAINE'],
 'unii': ['98PI200987'],
 'upc': ['0860010320167']}