FDA.reportPublic FDA data

87278-013 FOLLICULITIS TREATMENT CREAM

Manufacturer
Guangxi Keyun E-commerce Co., Ltd.
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:44:09

Label at a glance#

ProductFolliculitis Treatment Cream
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

FOLLICULITISINEA CAPITISLICHENPSORIASIS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

OTC - DO NOT USE SECTION

D0 NOT USE it on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT, avoid contact with the eyes, if contact occurs, rinse the eyes very thoroughly with water.

OTC - STOP USE SECTION

STOP USING AND ASK A PHYSICIAN if irritation occurs or there is no improvement within 4 weeks.
STOP USE AND ASK A DOCTOR if discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF YOUNG CHILDREN

DOSAGE & ADMINISTRATION SECTION

Wash the affected area and dry thoroughly. Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor.Supervise children in the use of the product.If the condition persists longer, consult a doctor.

INACTIVE INGREDIENT SECTION

Water
Gentiana
Sophora Flavescens
Rhinacanthus Nasutus
Stemona Tuberosa Lour
Herba Violae
Euphorbia Hirta
Murraya Exotica
Peppermint
Glycerin
Methylparaben
Propylene Glycol
Silicone Oil
Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87278-01387278-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GENTIANA LUTEA WHOLEYFL57437H5IACT
RHINACANTHUS NASUTUS WHOLEQW70YFP724IACT
POLYSILICONE-15F8DRP5BB29IACT
EUPHORBIA HIRTAL13YF113GNIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
STEMONA TUBEROSA WHOLE9373ZOT316IACT
VIOLA PHILIPPICA WHOLEO176VC3N54IACT
MURRAYA PANICULATA WHOLEY8ZAA3Z7WUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
PEPPERMINTV95R5KMY2BIACT
TRIETHANOLAMINE9O3K93S3TKIACT

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
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
ndc (package): 87278-013-01
ndc (product): 87278-013
ndc11 (package): 87278001301
spl id: 5625652a-193e-0318-e063-6294a90a56f3
spl set id: 5625652a-193d-0318-e063-6294a90a56f3

Reported adverse events (FAERS/openFDA)#

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