Otc - Active Ingredient
Miconazole Nitrate (2%)
Hydrocortisone (0.3%)
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Gembooxt Ringworm Cream (NDC 76986-020). 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.
Miconazole Nitrate (2%)
Hydrocortisone (0.3%)
Antifungal, Anti-ltch
Cures most athlete's foot between the toes.
Effectiveness on the bottom or sides of foot is unknown
Cures most jock itch and ringworm.
Relieves itching, burning, cracking, and scaling which accompany these conditions.
For external use only.
Do not use on nails or scalp
Do not use if allergic to any ingredients in this product
Do not use in or near the mouth or the eyes.
Do not use for vaginal yeast infections
Ask a doctor before use if pregnant or nursing.
When using this product, avoid contact with eyes, nose and mouth. lf contact occurs, rinse thoroughly with water
Stop using and ask a doctor if too much irritation occurs or irritation gets worse.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a poison control center immediately
For adults and children 12 years and older.
1. Wash and dry the affected area before application.
2. Athlete's Foot (between toes): Apply a thin layer to the affected area between and around the toes. Use twice daily(morning and night) for 1 week, or once daily for 2 weeks.or as directed by a doctor. Wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
3. Jock ltch and Ringworm: Apply a thin layer to the affectedarea once daily for 1 week, or as directed by a doctor.
4. Wash hands after use.
Children under 12 years: Ask a doctor.
CETYL ALCOHOL
STEARYL ALCOHOL
GLYCERYL STEARATE
GLYCERIN
MINERAL OIL
CETEARETH-25
ETHYLHEXYL PALMITATE
CAMPHOR
MENTHOLUM
GENTIANA SCABRA EXTRACT
CENTELLA ASIATICA EXTRACT
AVENA SATIVA (OAT) KERNEL EXTRACT
ROSA RUGOSA FLOWER EXTRACT
LACTOBACILLUS FERMENT
DIMETHICONE
GLYCERYL CAPRYLATE
ETHYLHEXYLGLYCERIN
1,2-HEXANEDIOL
ALLANTOIN
POTASSIUM LAURYL PHOSPHATE
DIPOTASSIUM PHOSPHATE
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
XANTHAN GUM
BUTYLENE GLYCOL
PENTYLENE GLYCOL
HYDROXYPHENYL PROPAMIDOBENZOIC ACID
ASCORBYL PALMITATE
TRIETHANOLAMINE
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