Active Ingredient(S)
Benzoyl peroxide 5%
Viachs Folliculitis Treatment Cream
FDA Label NDC 84558-033
12 label sections · Submitted to the FDA by Guangzhou Yusong Fine Chemicls Co., Ltd · 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 Viachs Folliculitis Treatment Cream (NDC 84558-033). 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)
· Penetrates hair follicles and pores to reduce follicle-associated bacteria
· Reduces redness and inflammation caused by follicular bumps
· Helps prevent new blemishes and follicular irritation from forming
Warnings
For external use only.
Do Not Use
· if you have very sensitive skin
· if you are allergic/sensitive to benzoyl peroxide
Otc - When Using
▪ avoid contact with eyes, lips, mouth and mucous membranes. If contact occurs, rinse thoroughly with water.
▪ avoid contact with hair and dyed/colored fabrics, bedding and towels - this product may cause bleaching.
▪ skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation
occurs, only use one topical acne medication at a time.
▪ reduce application frequency if mild redness, itching or peeling occurs.
▪ limit sun exposure and use sunscreen on treated areas, as skin may become more sensitive to sunlight.▪
Otc - Stop Use
▪ severe skin irritation occurs (intenderness, burning, swelling or blistering)
▪ symptoms show no improvement after 4 weeks of consistent use
▪ the condition worsens
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get
medical help or contact a Poison Control Center
immediately.
Directions
▪ Clean the affected area thoroughly and pat dry before application
▪ Apply a thin, even layer to affected skin 1 to 2 times daily
▪ If excessive dryness or irritation occurs,reduce to once daily or every other day tobuild skin tolerance
▪ For best results, use consistently as part of a daily body care routine
▪ Children under 12 years of age: consult adoctor before use
Other Information
▪ Store at 20" to 25°C (68° to 77°F)
▪ - Do not freeze
▪ - Keep tube tightly closed when not in use
Inactive Ingredients
AQUA, BIFIDA FERMENT FILTRATE GLYCERIN, CETYL ETHYLHEXANOATE.
BUTYLENE GLYCOL, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC TRIGLYCER-
IDE, BUTYROSPERMUM PARKII (SHEA) BUTTER, PEG-100 STEARATE, AMMONIUM
POLYACRYLOYLDIMETHYL TAURATE, MENTHOLUM, PORTULACA OLERACEA
EXTRACT. PEG-60 HYDROGENATED CASTOR OIL, CHRYSANTHELLUM INDICUM
EXTRACT, XANTHAN GUM, PENTAERYTHRI- TYL TETRA-DI-t-BUTYL HYDROXY
DROCINNAMATE, DISODIUM EDTA, ALOE BARBADENSIS EXTRACT
Package Label - Principal Display Panel
label
Undefined (Label)
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