Clotrimazole Cream USP 1%

Manufacturer
Delsam Pharma Llc
Effective date
2022-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:54:47

Label at a glance#

ProductCLOTRIMAZOLE 1%
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

• Cures most athlete's foot, jock itch and ringworm • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

• Wash the affected area and dry thoroughly • Apply a thin layer over affected area twice daily (morning and night) • Supervise children in the use of this product • For athlete's foot pay special attention to the 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 •...

Storage and handling

• Store at temperature not exceeding 30°C (86°F).    Do not freeze.

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, jock itch and ringworm
• Relieves itching, burning, cracking, scaling and discomfort which 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 the eyes

Stop use and ask a doctor if
• Irritation occurs
• There is no improvement within 4 weeks (for athlete's foot and ring worm) 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

• Wash the affected area and dry thoroughly
• Apply a thin layer over affected area twice daily (morning and night)
• Supervise children in the use of this product
• For athlete's foot pay special attention to the 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
• If condition persists longer, consult a doctor
• this product is not effective on the scalp or nails

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sodium Dihydrogen Orthophosphate, White soft paraffin, Sorbitan monostearate, Cetostearyl alcohol, Light liquid paraffin, Propylene glycol, Glycerin, Cetomacrogol -1000, Purified water.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• Store at temperature not exceeding 30°C (86°F).
   Do not freeze.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

1-866-826-1306 between 11 am to 4 pm EST, Monday-Friday (or) mail to delsamppharma@yahoo.com

SPL UNCLASSIFIED SECTION

​• Relieves Itching & Burning
• Relieves Cracking and Scaling
• Grease less
• Non-Staining

Distributed by:
DELSAM PHARMA LLC
MAMARONECK NY 10543

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cream-135cream-135

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72570-13572570-135-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0326a9b1-a63a-4da3-87bf-a5b1b4df1d60a4b08b10-6328-4e58-8850-7529673b41242023-03-15WarningsExact identifier
spl set id: a4b08b10-6328-4e58-8850-7529673b4124

Reported adverse events (FAERS/openFDA)#

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