Active Ingredient
Miconazole Nitrate 2%
Beilloso Balanitis Relief Cream
FDA Label NDC 85248-138
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangxi Yudexi Pharmaceutical Co., Ltd for the product Beilloso Balanitis Relief (NDC 85248-138). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
reduce inflammation.soothe irritated skin
Use
Helps relieve redness, itching & irritation from balanitis,and soothes discomfort from other fungal skin conditions in sensitive areas.
Warnings
For external use only.
Do Not Use
under 2 years of age unless directed by a doctor.
When Using
avoid contact with the eyes.If contact occurs. rinse the eyes very thoroughly with water
Stop Use
if irritation occurs,symptoms perist for more than 2 weeks,or symptoms worsen after initial improvement.
Ask Doctor
if irritation occurs,symptoms perist for more than 2 weeks,or symptoms worsen after initial improvement.
Keep Oot Of Reach Of Children
lf swallowed. get medical help or contact a Poison Control Center right away.
Directions
·Dispense 2 pumps of cream onto clean fingers.·Apply to affected area on clean, dry skin 1-2x daily,gently massage until fully absorbed.·For first-time users: Do a small patch test before full use
Other Information
Store at 59-86°F(15-30°C）
Inactive Ingredients
water,allantoin.beeswax,cedarwood oil, cottonseed oil, jojoba oil lavender oil, magnesium oxide,MCT oil, silver stearate, zinc oxide.
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