Otc - Active Ingredient
Miconazole Nitrate 2%
Hydrocortisone 0.3%
Nerante Antifungal Cream
FDA Label NDC 87681-001
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 Xinhongda Trading Service Co., Ltd. for the product Nerante Antifungal Cream (NDC 87681-001). 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
Anti-Itch
Indications & Usage
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.
Warnings
For external use only.
Ask a doctor before use if pregnant or nursing.
Otc - Do Not Use
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.
Otc - When Using
When using this product, avoid contact with eyes, noseand mouth. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop using and ask a doctor if too much irritation occurs or irritation gets worse.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidentalingestion, get medical help or contact a poison control centerimmediately.
Dosage & Administration
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, ventilatedshoes and change shoes and socks at least once daily.
3.Jock Itch and Ringworm: Apply a thin layer to the affected area once daily for 1 week, or as directed by a doctor.
4.Wash hands after use.
Children under 12 years: Ask a doctor.
Inactive Ingredient
WATER
CETYL ALCOHOL
STEARYL ALCOHOL
GLYCERYL STEARATE
GLYCERIN
MINERAL OIL
CETEARETH-25
STEARIC ACID
ETHYLHEXYL PALMITATE
CAMPHOR
MENTHOL
GENTIANA SCABRA EXTRACT
BUTYLENE GLYCOL
HYDROXYACETOPHENONE
CENTELLA ASIATICA EXTRACT
AVENA SATIVA (OAT) KERNEL EXTRACT
ROSA RUGOSA FLOWER EXTRACT
LACTOBACILLUS FERMENT
BUTYLENE GLYCOL
DIMETHICONE
GLYCERYL CAPRYLATE
HYDROXYACETOPHENONE
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
Package Label.Principal Display Panel
Label (Label)
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