MedPath

AUVON Pain Relief Cream

83391-009

Approved
Approval ID

358c2632-3b90-1c54-e063-6294a90ad461

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

SHENZHEN YUWEN E-COMMERCE CO., LTD.

DUNS: 544559614

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lidocaine

PRODUCT DETAILS

NDC Product Code83391-009
Application NumberM017
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
Generic NameLidocaine

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ALOE VERA LEAF OILInactive
Code: JQ7YW886UQ
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
RACEMENTHOLInactive
Code: YS08XHA860
Classification: IACT
LIDOCAINEActive
Quantity: 4 g in 100 g
Code: 98PI200987
Classification: ACTIB
CARBOMER 940Inactive
Code: 4Q93RCW27E
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

83391-009-0383391-09-0283391-009-01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/20/2025

For the temporay relief of pain

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Lidocaine 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Topical Analgestic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Please read all directions and warnings as follows and use only as directed. For external use only.
Keep out of reach of children and pets. If ingested, get medical help right away.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/20/2025

Drug Facts

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/20/2025

Do not use

if you're allergic to the listed ingredients.

if the package arrives damaged or opened.

if you are pregnant or breast-feeding.

at the same time as other topical analgesics.

on eyes, mucous membranes, cuts, wounds damaged, broken, swolen. or irritated skin.

In large quantities. particularly over raw surfaces or blistered area

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/20/2025

Stop use and ask a doctor
if symptoms persist for more than / days or clear up and occur again within a few davs.

if you experience any signs of deterioration or skin iniurv. such as redness, irritation, sweling, or bistering.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of reach of children and pets. If ingested, get medical help right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

Apply a thin layer to the affected area every 6 to 8 hours.

Children under 12 years of age:do not use, consult a doctor.

Use no more than three times in a day.

Wash hands after use.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/20/2025

Store it in a dry place at room temperature between 20-25°C (68-77°F) and away from direct sunlight.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Aloe oil, Carbomer 940, Ethyl Alcohol, Ethyl Paraben, Glycerin, Lavander oil,
Menthol, Polysorbate 80, Trolamine, Water

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AUVON Pain Relief Cream - FDA Approval | MedPath