Active Ingredient(S)
BENZOYL PEROXIDE 10%
Folliculitis Cream
FDA Label NDC 84558-034
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 Folliculitis Cream (NDC 84558-034). 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. Avoid contact
with eyes, lips, and mouth. May bleach hair or dyed
fabrics. Avoid sun exposure, use sunscreen. Skin
irritation may occur.
Do Not Use
Do not use if inner seal is broken.
Otc - When Using
avoid contact with the eyes.
Otc - Stop Use
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, please seek medical help immediately or contact the poison control center.
Directions
Clean skin thoroughly. Apply a thin
layer to affected areas 1-3 times daily.Start with
once daily; reduce frequency if dryness occurs.
Other Information
Storeat20°-25°C(68°-77°F).
Inactive Ingredients
AQUA,GLYCERIN,C12-15ALKYL BENZOATE,PROPYLENE GLYCOL,GLYCERYL STEARATE,CETEARYL ALCOHOL,
SQUALANE,ALOE BARBADENSIS LEAF JUICE, DIMETHICONE、HYDROXYETHYL ACRYLATE/SODIUM
ACRYLOYLDIMETHYL TAURATE COPOLYMER, PHENOX-YETHANOL、PANTHENOL、PEG-100 STEARATE、
POLYSORBATE 80, MAGNESIUM ALUMINOMETASI-LICATE, CERAMIDE NP,SODIUM HYDROXIDE,ALLANTOIN,
SCUTELLARIA BAICALENSIS ROOT EXTRACT, FORSY-THIASUSPENSA FRUIT EXTRACT, PORTULACA OLERACEA
EXTRACT, MAGNOLIA OFFICINALIS BARK EXTRACT、CALENDULA OFFICINALIS FLOWER EXTRACT,
MELALEUCA ALTERNIFOLIA(TEA TREE) LEAF OIL, MENTHA PIPERITA OIL、 MENTHYL LACTATE,
ETHYLHEXYLGLYCERIN,DISODIUM EDTA
Package Label - Principal Display Panel
Undefined (Label)
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