Update-85498-011-01

Manufacturer
SpineStatus LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:37:13

Label at a glance#

ProductAosorw Antifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

  • For the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis).
  • Relieves itching, burning, cracking, scaling, and discomfort caused by fungal infections.

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

before use if you have

  • a condition that covers a large area of the body
  • sensitive skin or any known allergies to the ingredients

OTC - DO NOT USE SECTION

on children under 2 years of age except under the advice and supervision of a doctor.

OTC - WHEN USING SECTION

avoid contact with eyes.

OTC - STOP USE SECTION

and ask a doctor if

  • irritation occurs.
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch).

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly.
  • apply a thin layer 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 and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks.
  • if conditions persist longer, ask a doctor.
  • this product is not effective on the scalp or nails.

OTHER SAFETY INFORMATION

Store at 20ºC to 25ºC (68ºF to 77ºF).
Close the cap tightly after use.

INACTIVE INGREDIENT SECTION

Sophora Flavescens Root, Glycerin, Propylene Glycol, Peppermint Oil, Sodium Acrylate, Sodium Acryloyldimethyl Taurate, Isohexadecane, Polysorbate-80, Dimethicone, Triethanolamine

OTC - QUESTIONS SECTION

Contact us at service@aosorw.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product imageproduct image

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130199284038585GTIN-13: 0199284038585
EAN-13: 0199284038585
GTIN-12: 199284038585
UPC-A: 199284038585
GTIN storage (14 digits): 00199284038585
product image.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85498-01185498-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32026-03-04full-release2026-06-01 01:49:00
22025-11-03monthly-update2026-06-03 17:38:37

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
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
ndc (package): 85498-011-01
ndc (product): 85498-011
ndc11 (package): 85498001101
spl id: 5567f20a-6854-663b-e063-6394a90abb17
spl set id: 31f4b0eb-b8aa-7ccb-e063-6394a90ad981

Reported adverse events (FAERS/openFDA)#

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