FDA.reportPublic FDA data

Dermachange Jock

Manufacturer
Private label Beauty and Wellness | Derma Care Research Labs, LLC
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:25

Label at a glance#

ProductDermachange Jock
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

For the cure of athlete's foot and jock itch. Relieves itching and chafing associated with jock itch.

WARNINGS SECTION

For external use only. Do not use on children under 2 years of age unless directed by a doctor or for diaper rash. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Jock Powder

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.

Supervise children in the use of this product.

Use daily for 2 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

Foot Powder

Cleanse the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily or as directed by a doctor.

For athlete's foot: pay special attention to space between toes; wear well-fitting ventilated shoes and change socks at least once daily.

Supervise children in the use of this product.

Use daily for 4 weeks.

If the condition persists, consult a doctor.

This product is not effective on the scalp or nails.

INACTIVE INGREDIENT SECTION

Corn Starch, Fragrance, Potassium Sorbate, Rice Starch, Sodium Benzoate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermachange Jock Powder, NDC 83520-961-21

labellabel

Dermachange Foot Powder, NDC 83520-961-02

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN1
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1
998461miconazole nitrate 2 % Topical PowderSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83520-961-02Dermachange Jock71 g in 1 BOTTLE, PLASTICPOWDER711
83520-961-21Dermachange Jock71 g in 1 BOTTLE, PLASTICPOWDER711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83520-961DERMACHANGE JOCK (MICONAZOLE NITRATE) POWDER [PRIVATE LABEL BEAUTY AND WELLNESS]1Current NDC, 2 package rows20240307_12eef049-76c9-1450-e063-6394a90a00ea.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83520-96183520-961-21, 83520-961-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
SODIUM BENZOATEOJ245FE5EUIACT
STARCH, CORNO8232NY3SJIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
STARCH, RICE4DGK8B7I3SIACT

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
Dermachange JockMICONAZOLE NITRATEPrivate label Beauty and Wellness12eef049-76c9-1450-e063-6394a90a00ea2024-03-05WarningsExact identifier
ndc (package): 83520-961-02
ndc (package): 83520-961-21
ndc (product): 83520-961
ndc11 (package): 83520096102
ndc11 (package): 83520096121
spl id: 12eef049-76c8-1450-e063-6394a90a00ea
spl set id: 12eef049-76c9-1450-e063-6394a90a00ea

Reported adverse events (FAERS/openFDA)#

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