FDA.reportPublic FDA data

GeriGentle Miconazole Nitrate Anti-Fungal Powder Talc

Manufacturer
GERI-GENTLE CORPORATION
Effective date
2026-06-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-07-15 00:33:05

Label at a glance#

ProductGeriGentle Miconazole nitrate
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

Dosage and administration

clean the affected area & dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once daily for athlete's foot & ringworm, use daily for 4 weeks; for jock itch,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

fFor the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) ■Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch or itching, burning feet

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

: ■On children under 2 years of age unless directed by a doctor ■For diaper rash

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

■Irritation occurs

■There is no improvement within 2 weeks when used for the treatment of jock itch ■There is no improvement within 4 weeks when used for athlete's foot or ringworm

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area & dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once daily
  • for athlete's foot & ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal Anhyhdrous Silica, Talcum Powder

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Pincipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts and Principal Display PanelDrug Facts and Principal Display Panel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130648289041262GTIN-13: 0648289041262
EAN-13: 0648289041262
GTIN-12: 648289041262
UPC-A: 648289041262
GTIN storage (14 digits): 00648289041262		Tender Antifungal Powder Miconazole - Customer.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-16569771-165-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-10-27full-release2026-06-01 01:40:55
22024-06-25full-release2026-06-01 00:14:09

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
GeriGentle Miconazole nitrateANTIFUNGALGERI-GENTLE CORPORATION0ae03b4a-06c8-ddf9-e063-6294a90ad1052026-06-16WarningsExact identifier
ndc (package): 69771-165-03
ndc (product): 69771-165
ndc11 (package): 69771016503
spl id: 6ff1ce91-f486-4701-ae08-909da151b402
spl set id: 0ae03b4a-06c8-ddf9-e063-6294a90ad105

Reported adverse events (FAERS/openFDA)#

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