Otc - Active Ingredient
Terbinafine Hydrochloride 1%
Athlete Foot Cream
FDA Label NDC 85398-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Athlete Foot Cream (NDC 85398-006). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
- cures most athlete's foot (tinea pedis)
- cures most jock itch (tinea crurs) and ringworm (tinea corporis)
- relieves itching, burning, cracking and scaling which accompany these conditions
Warnings
For external use only
Otc - Do Not Use
- on nails or scalp
- in or near the mouth or eyes
- for vaginal yeast infections
Otc - When Using
do not get into eyes, if eye contact occurs, rinse thoroughly with water.
Otc - Stop Use
stop use and ask a doctor if too much irritation occurs or gets worse.
Otc - Keep Out Of Reach Of Children
if swallowed, call a poison control centre or get medical help right away.
Dosage & Administration
■ adults and children 12 years and over
■ use the tip of the cap to break the seal and open the tube
■ wash the affected skin with soap and water and dry completely before applying
■ for athlete’s foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
■ between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor
■ on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor
■ for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor
■ wash hands after each use
■ children under 12 years: ask a doctor
Other Safety Information
■ Do not use if seal on tube is broken or is not visible.
■ Store at 68–77°F (20–25°C)
Inactive Ingredient
Allantoin, Glycerin, Propylene Glycol, PCA Dimethicone, Ethylparaben, Glyceryl Stearate, Primary Alcohol Ethoxylate, Alumen, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Aloe Barbadensis Leaf Juice, Parfum
Otc - Questions
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