FDA.reportPublic FDA data

SYLVIRENE NUMBING

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:45

Label at a glance#

ProductSYLVIRENE NUMBING
Active ingredientMENTHOL
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

Menthol 5% （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.·Symptoms 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.·Symptoms 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

55

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039690menthol 5 % Topical CreamPSN1
1039690menthol 50 MG/ML Topical CreamSCD1
1039690menthol 5 % Topical CreamSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843980852GTIN-13: 6979843980852
EAN-13: 6979843980852
GTIN storage (14 digits): 06979843980852		be1ebd55b34be58710bb4960c7074321.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-163-01SYLVIRENE NUMBING50 g in 1 BOTTLECREAM501

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
85248-16385248-163-01

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
CARBOMER 934Z135WT9208IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SOYBEAN LECITHIN1DI56QDM62IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AACTIB
BENZYL ALCOHOLLKG8494WBHIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
ndc (package): 85248-163-01
ndc (product): 85248-163
ndc11 (package): 85248016301
spl id: 4d47e8c7-d294-bf63-e063-6294a90a5fd9
spl set id: 4d47e8c7-d293-bf63-e063-6294a90a5fd9

Reported adverse events (FAERS/openFDA)#

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