ACINO PRODUCTS - CLOTRIMAZOLE (TOPICAL SOLUTION) USP 1% (68784-301)

Manufacturer
ACINO PRODUCTS LIMITED LIABILITY COMPANY
Effective date
2023-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:36:51

Label at a glance#

ProductCLOTRIMAZOLE
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

Cures most • Athlete's foot (tinea pedis) • Jock Itch (tinea cruris) • Ringworm (tinea corporis) Effectively relieves • Itching • Cracking • Burning • Discomfort which can accompany these conditions • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use...

Dosage and administration

This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. 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 ...

Storage and handling

Store at 15° to 30°C (59° to 86°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CLOTRIMAZOLE USP, 1%

PURPOSE

OTC - PURPOSE SECTION

ANTIFUNGAL

USES

INDICATIONS & USAGE SECTION

Cures most

• Athlete's foot (tinea pedis)
• Jock Itch (tinea cruris)
• Ringworm (tinea corporis)

Effectively relieves
• Itching
• Cracking
• Burning
• Discomfort which can accompany these conditions
• This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
• 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; change shoes and socks at least once daily.

WARNINGS

WARNINGS SECTION

• For external use only
Ask a doctor before use on children under 2 years of age
When using this product avoid contact with eyes
Stop use 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 - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
  • 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; change shoes and socks at least once daily.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at 15° to 30°C (59° to 86°F)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

polyethylene glycol 400

QUESTIONS

OTC - QUESTIONS SECTION

call 1-877-227-2594

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACINO_clotrimazole carton 10mLCPACINO_clotrimazole carton 10mLCP

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68784-30168784-301-01, 68784-301-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
CLOTRIMAZOLEG07GZ97H65ACTIB

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
f47384f9-f632-48bd-e053-2995a90ab999d70dbfaa-104e-48ae-97e5-57bf7c8ef1442023-02-11WarningsExact identifier
spl id: f47384f9-f632-48bd-e053-2995a90ab999
spl set id: d70dbfaa-104e-48ae-97e5-57bf7c8ef144

Reported adverse events (FAERS/openFDA)#

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