Active Ingredient(S)
Benzoyl peroxide 5%
Jvoravix 5% Benzoyl Peroxide Folliculitis Treatment Cream
FDA Label NDC 84558-035
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 Jvoravix 5% Benzoyl Peroxide Folliculitis Treatment Cream (NDC 84558-035). 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 hair follicles and pores to help reduce
acne-causing bacteria, reduce redness and
inflammation, and help prevent new blemishes.
Warnings
For external use only
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, even layer to affected areas 1 to 2 times daily
▪ Start with once daily, gradually increase to 2 times daily if needed
▪ If excessive dryness or peeling occurs, reduce application to once a day or every other day
▪ Children under 12 years of age: consult a doctor 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, HYDROGENATED PALM KERNEL OIL, CETYL
ETHYLHEXANOATE, BUTYLENE GLYCOL, CETEARYL ALCOHOL, CAPRYLIC/CAPRIC
TRIGLYCERIDE, BUTYROSPERMUM PARKII (SHEA) BUTTER, THEOBROMA CACAO
(COCOA) SEED BUTTER, PEG-100 STEARATE, AMMONIUM POLYACRYLOYLDIMETHYL
TAURATE, MENTHOL, PORTULACA OLERACEA EXTRACT, PEG-60 HYDROGENAT-
ED CASTOR OIL,MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, CHRYSANTHELLUM
INDICUM EXTRACT, XANTHAN GUM, PENTAERYTHRITYL TETRA-DI-t-BUTYL
HYDROXYHYDROCINNAMATE, DISODIUM EDTA, ALOE BARBADENSIS EXTRACT
Package Label - Principal Display Panel
label
Undefined (Label)
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