Active Ingredient
Benzoyl Peroxide 5%
Zmztuhua Folliculitis Treatment Cream
FDA Label NDC 87298-051
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 Hechuang Commercial Service Co.,ltd. for the product Zmztuhua Folliculitis Treatment Cream (NDC 87298-051). 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, purpose, inactive ingredients, uses, warnings, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical antibacterial
Inactive Ingredients
water, caprylic/capric triglyceride, cetearyl alcohol, glycerin, cetyl alcohol, dimethicone, squalane, glyceryl stearate, PEG-100 stearate, carbomer, tromethamine, phenoxyethanol, ethylhexylglycerin, allantoin, aloe barbadensis leaf extract, melaleuca alternifolia (tea tree) leaf oil, centella asiatica extract, ceramide NP, ceramide AP, ceramide EOP, cholesterol,
phytosphingosine, xanthan gum
Uses
Uses
● for the treatment of folliculitis
● helps reduce the number of bumps and pustules
● associated with folliculitis
● helps relieve redness and irritation
● helps prevent recurrence
Warnings
Warnings
For external use only.
Do not use if you
● have very sensitive skin
● are sensitive to benzoyl peroxide
When using this product
do not get into eyes, lips, or mouth. If contact occurs, flush thoroughly with water. Avoid contact with hair and dyed fabrics, which may be bleached.
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
● irritation or redness becomes severe
● 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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
● clean the affected area
● apply a thin layer to affected area
● start once daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor
● if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Other Information
Other information
● store at 20°-25°C (68°-77°F)
Description
8X FAST ACTING
5% BENZOYL PEROXIDE
POWERED BY 4-PART CARE FORMULA
TARGET
5% Benzoyl Peroxide
Helps clear bacteria and unclog follicles
PURIFY
Tea Tree Oil
Naturally purifies and refreshes
COMFOR
Centella Asiatica
Soothes irritation and calms redness
SUPPORT
Ceramides
Strengthens skin barrier and locks in moisture
SCALP & HAIRLINE
Helps relieve scalp folliculitis, bumps and irritation.
BEARD LINE & NECK
Helps soothe bumps caused by shaving, trimming or friction.
CHEST & BACK
Helps reduce breakouts in sweat-and friction-prone areas.
SHOULDERS & THIGHS
Helps clear bumps on hair-bearing skin.
Rems Administrative Information
Distributed by:
ZmztuhuaLinyi Houdaosheng Health Management Consulting Co., Ltd.
Linyi City, Shandong Province 276000, China
[email protected]
www.zmztuhua.com
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Principal Display Panel (Label)
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