S-Cream MICONAZOLE NITRATE 2%

Manufacturer
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED
Effective date
2021-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:56

Label at a glance#

ProductS-Cream MICONAZOLE NITRATE 2%
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

• Effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) • For effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.

Dosage and administration

• Clean the affected area and 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, and change shoes and socks at least once daily • For athlete's foot and ringworm: use daily for 4 wee...

Storage and handling

• Do not use if seal is damaged or is not visible • To open, unscrew cap, pull tab to remove foil seal • store at temperature not exceeding 30°C (86°F). Do not freeze. • see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate USP 2%

PURPOSE 

OTC - PURPOSE SECTION

Antifungal

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cetostearyl alcohol, Cetomacrogol 1000, Paraffin wax, Microcrystalline wax, Light liquid paraffin, Polyethylene Glycol, Chlorocresol and purified water

USES

INDICATIONS & USAGE SECTION

• Effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)

• For effective relief of itching, scaling, cracking, burning and discomfort that can accompany these conditions.

WARNINGS

WARNINGS SECTION

For external use only

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

Stop use and ask a doctor if
• Irritation occurs • Condition persists • There is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.
If swallowed get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Clean the affected area and 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, and change shoes and socks at least once daily • For athlete's foot and ringworm: use daily for 4 weeks. • For jock itch: use daily for 2 weeks • Not effective on the scalp or nails

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• Do not use if seal is damaged or is not visible • To open, unscrew cap, pull tab to remove foil seal • store at temperature not exceeding 30°C (86°F). Do not freeze. • see carton or tube crimp for lot number and expiration date

Questions or comments?

OTC - QUESTIONS SECTION

1-800-572-6632 between 9am and 4pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

ANTI-FUNGAL CREAM

Manufactured by :

Global pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Miconazole12Miconazole12

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73921-01273921-012-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
f42ad874-1134-1ea4-e053-2995a90a9e0319a481b9-aa37-423d-99b1-53c5e2c7091b2023-02-08WarningsExact identifier
spl set id: 19a481b9-aa37-423d-99b1-53c5e2c7091b

Reported adverse events (FAERS/openFDA)#

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