Active Ingredient(S)
Benzoyl peroxide 5%
Elorevia Folliculitis Treatment Cream
FDA Label NDC 84558-032
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 Yusong Fine Chemicls Co., Ltd for the product Elorevia Folliculitis Treatment Cream (NDC 84558-032). 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(s), purpose, use, warnings, 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
Purpose
Topical antibacterial
Use
For the treatment of folliculitis
Helps reduce follicle bumps and pustules
Helps relieve redness and irritation
Warnings
For external use only.
Do Not Use
Have very sensitive skin
Are sensitive to benzoyl peroxide
Otc - When Using
Avoid contact with eyes, lips, mouth, and mucousmembranes.
If contact occurs, rinse thoroughly with water.
Avoid contact with hair and dyed fabrics, which may be bleached.
Otc - Stop Use
Severe irritation or redness develops.
Condition worsens.
Symptoms persist for more than 7 days or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a
Poison Control Center right away.
Directions
Clean the affected area.
Apply a thin layer to the affected area.
Apply once daily. If needed, increase to twice daily.
lf bothersome dryness or peeling occurs, reduce application to once daily or every other day.
Other Information
store at 20°-25°C (68°-77°F), Close the cap
tightly after use.
Inactive Ingredients
Water, Glycerin, C12-15 Alkyl Benzoate,
Propylene Glycol, Glyceryl Stearate, Cetearyl
Alcohol, Squalane, Aloe Barbadensis Leaf
Juice, Dimethicone, Hydroxyethy| Acrylate/
Sodium Acryloyldimethyl Taurate Copolyer,
Phenoxyethanol, Panthenol, PEG-100
Stearate, Polysorbate80, Magnesium
Aluminum Silicate, Ceramide NP,Sodium
Hydroxide, Allantoin, Scutellaria Baicalensis
Root Extract, Forsythia Suspensa Fruit Extract,
Portulaca Oleracea Extract, Magnolia Officinalis
Bark Extract, Calendula Officinalis Flower
Extract, Melaleuca Alternifolia(Tea Tree) Leaf
Oil, Menthyl Lactate, Ethylhexylglycerin,
Disodium EDTA.
Package Label - Principal Display Panel
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Label (Label)
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