Active Ingredients
GLYCERIN 10g
Antifungal Cream
FDA Label NDC 87123-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Guoyoumi Biotechnology Co Ltd for the product Antifungal Cream (NDC 87123-003). 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 ingredients, purpose, uses[indications & usage section], warnings, dosage and administration, do not use, when using section, stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal (for the treatment of fungal skin infections)
Uses[Indications & Usage Section]
For the treatment of superficial fungal infections of the skin such as athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by susceptible fung
Warnings
1. For external use only.2. Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.3. Do not use on broken or irritated skin.4. If irritation, redness, swelling, or itching worsens, discontinue use and consult a doctor.5. If condition persists after 4 weeks of use, consult a doctor.6. Do not use if you are allergic to any ingredient in this product.7. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
Dosage And Administration
Clean and dry the affected area thoroughly. Apply a thin layer of the cream to the affected skin and surrounding area twice daily (morning and evening) or as directed by a doctor. Continue use for 1-2 weeks after symptoms disappear to prevent recurrence.
Do Not Use
- Do not use on children under 2 years of age unless directed by a doctor.- Do not use for vaginal yeast infections or nail fungal infections.- Do not use if the product is expired or the packaging is damaged.
When Using Section
1. Use only as directed.2. Do not cover the treated area with bandages or dressings unless directed by a doctor.3. Avoid using other topical products on the same area unless advised by a doctor.4. If using for athlete's foot, wear well-fitting, ventilated shoes and change socks daily.5. For jock itch, wear loose-fitting, breathable clothing.
Stop Use
Stop use and ask a doctor if:- Irritation, burning, stinging, or redness occurs and persists.- The infection spreads or worsens.- New symptoms appear.- Condition does not improve after 4 weeks of treatment.
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
WATER, PROPYLENE GLYCOL, HELIANTHUS ANNUUS(SUNFLOWER)SEED OlL,chamomile extract,Cetearyl Alcohol,ETHYLHEXYLPALMITATEBUTYROSPERMUM PARKII (SHEA) BUTTER, 1,2-HEXANEDIOLHYDROXYACETOPHENONE, Cetearyl Glucoside, TOCOPHERYL ACETATECARBOMER, TRIETHANOLAMINE, MENTHOLUM, SOPHORAFLAVESCENSEXTRACT, ARTEMISIA ARGYI LEAF EXTRACT, GLYCYRRHIZAURALENSIS(LICORICE) EXTRACT, SODIUM HYALURONATE, OLIGOPEPTIDE-1
Principal Display Panel
01 (1)
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