FDA.reportPublic FDA data

SHINGBASE Topical Analgesic Cream

Manufacturer
JOONEM LLC
Effective date
2024-02-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:11:09

Label at a glance#

ProductSHINGBASE Topical Analgesic
Active ingredientLIDOCAINE, MENTHOL
Label structure7 sections

Dosage and administration

use only as directed  adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

Temporary relieves minor pain

Warnings:

WARNINGS SECTION

Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children to avoid accidental ingestion!

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact the poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • use only as directed 
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other Information:

SPL UNCLASSIFIED SECTION

Store at 20 to 25 C (68 to 77F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

L-arginine, Sodium Benzonate, Rectified Spirit, Disodium EDTA, Phenoxyetanol, Polysorbate 20, DM Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80327-002-012024-01-30C16284748780-11030e365-21e4-111a-e063-dadaa90a10e2SHINGBASE Topical Analgesic Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80327-002SHINGBASE TOPICAL ANALGESIC (LIDOCAINE, MENTHOL) CREAM [JOONEM LLC]6Legacy NDC20240220_afebbc7a-ed03-9b3c-e053-2a95a90a3d95.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80327-00280327-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARGININE94ZLA3W45FIACT
SODIUM BENZOATEOJ245FE5EUIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
3ac6260c-ca8b-030d-e063-6294a90ab5ecafebbc7a-ed03-9b3c-e053-2a95a90a3d952025-07-25WarningsExact identifier
spl set id: afebbc7a-ed03-9b3c-e053-2a95a90a3d95

Reported adverse events (FAERS/openFDA)#

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