Active Ingredient
Active Ingredient Purpose
Clotrimazole 1.0% Antifungal
Antifungal Cream
FDA Label NDC 68001-475
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bluepoint Laboratories for the product Antifungal Cream (NDC 68001-475). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, warnings, indications and usage, dosage and administration, keep out of reach of children, inactive ingredients, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
- For the treatment of most athlete's foot (tinea pedis), jock itch (tinea crusis), Ringworm (tinea corporis).
- Relieves itching, scaling, cracking, burning, redness, soreness, irritation discomfort and chafing associated with jock itch.
Warnings
Do not use:
- on children under 2 years of age unless directed by a doctor.
- for diaper rash
- Avoid contact with eyes.
- irritation occurs
- there is no improvement within 2 weeks, when used for the treatment of jock itch reaction develops
- there is no improvement within 4 weeks, when used for athlete's foot or ringworm.
When using this product
Stop use and ask a doctor if
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications And Usage
- Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
Dosage And Administration
- 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 scalp or nails.
Keep Out Of Reach Of Children
KEEP OUT Of REACH Of CHILDREN
if swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Inactive Ingredients: Cetomacrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraben
Otc - Questions
Contact 1-800-707-4621
Storage And Handling
- Store at room temperature
- Preserve in thight containers
Principal Display Panel
Package Label.Principal Display Panel
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