Otc - Active Ingredient
Active Ingredient
Clotrimazole 1%
Purpose
Antifungal
Athletes Foot Cream
FDA Label NDC 87365-004
7 label sections · Submitted to the FDA by Jiangxi He-oumei Health Industry Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi He-oumei Health Industry Co., Ltd. for the product Athletes Foot (NDC 87365-004). 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, otc - keep out of reach of children, warnings, inactive ingredient, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
cures most athlete's foot (tinea pedis)
relieves itching, burning, cracking, scaling, and discomf
ort associated with athlete's foot
Otc - 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.
Warnings
Warnings
For external use only.
Do not use on children under 2years of age unless directe
d by a doctor.
When using this product avoid contact with the eyes.
Stop use and ask a doctor if irritation occurs there is no im
provement within 4 weeks.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control
Center right away.
Inactive Ingredient
Inactive Ingredients
Cetostearyl Alcohol, Butylated Hydroxytoluene (BHT), Pr
opylene Glycol, Phenoxyethanol, Purified Water.
Dosage & Administration
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 inthe use of this product pay special attention to spaces between the toes;
Indications & Usage
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 inthe use of this product pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily if condition persists longer, consult a doctor this product is not effective on the scalp or nails
* Please review the disclaimer below.
