Drug Facts
Active Ingredient: Purpose
Clotrimazole 1% Antifungal
Clotrimazole
FDA Label NDC 54162-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Corp for the product Clotrimazole (NDC 54162-018). 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 drug facts, uses, directions, warnings, inactive ingredients, otc - keep out of reach of children, storage and handling, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Treats most athlet's foot, jock itch and ringworm, relieves itching, scaling, burning, irritation, and discomfort
Directions
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 products.This products does not work on the scalp or nail. For athlet's foot and ringworm pay special attention to spaces between the toes: wear well fitting, ventilates shoes, and change shoes and socks at least once every day. Use every day for 4 weeks. For jock itch, use every day for 2 weeks. If condition lasts longer, contact a doctor.
Warnings
FOR EXTERNAL USE ONLY
When using this product do not get in to the eyes. Stop use and ask doctor if irritation occurs there is no improvement within 4 weeks (for athlet's foot or ringworm) or within 2 weeks (for jock itch). Do not use on children under 2 years, unless directed by a doctor.
Inactive Ingredients
Benzyl alcohol, Cetearth 20, Cetyl alcohol, Citric acid, Paraffin wax, Petrolatum, Polysorbate 80, Sodium citrate, Sorbitan sesquioleate, Stearyl alcohol, Water
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
In the event of accidental ingestion, contact a Poison Control Center right away.
Storage And Handling
Store between 20'-30'C (36'-86'F)
Dosage & Administration
Use every day for 4 weeks. For jock itch, use every day for 2 weeks. if conditon lasts longer, contact a doctor
Package Label.Principal Display Panel
Label Of Tube (Clmz14g)
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