Active Ingredient(S)
Benzoyl peroxide 5%
5% Benzoyl Peroxide Folliculitis Cream
FDA Label NDC 84558-026
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 5% Benzoyl Peroxide Folliculitis Cream (NDC 84558-026). 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
Treats and helps clear mild folliculitis and acne vulgaris (pimples,
whiteheads, and blackheads) by penetrating pores to help reduce
acne-causing bacteria, reduce redness and inflammation, and help
prevent new blemishes.
Warnings
For external use only.
Do Not Use
Do not use if you are sensitive to benzoyl peroxide.
Otc - When Using
.avoid unnecessary sun exposure and use a sunscreen.
.avoid contact with the eyes, lips, and mouth.
.avoid contact with hair and dyed fabrics, which may be bleached by this product.
.skin irritation may occur, characterized by redness, burning, itching,
peeling, or swelling. Reduce frequency of use if irritation occurs.
Otc - Stop Use
. irritation becomes severe.
. no improvement is seen after 6 weeks of consistent use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact
Poison Control right away.
Directions
Clean the skin thoroughly before applying. Apply a thin layer to affected
areas 1 to 3 times daily. Start with once daily, gradually increase to 2-3
times if needed. If dryness or peeling occurs, reduce to once daily or
every other day.
Other Information
Store at 20°-25°C(68°-77°F). Do not use if the carton or inner seal is broken.
Inactive Ingredients
Water, Glycerin, C12-15 Alkyl Benzoate, Propylene Glycol, Glyceryl
Stearate, Cetearyl Alcohol, Squalane, Aloe Barbadensis Leaf Juice,
Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate
Copolymer, Phenoxyethanol, Panthenol, PEG-100 Stearate,
Polysorbate 80, 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, Menthy| Lactate, Ethylhexylglycerin, Disodium EDTA
Package Label - Principal Display Panel
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