Active Ingredients
Benzoyl Peroxide 4%
Face Acne Wash Gel
FDA Label NDC 84365-008
14 label sections · Submitted to the FDA by Shield Skin Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shield Skin Llc for the product Face Acne Wash (NDC 84365-008). 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 ingredients, use, purpose, warnings, do not use if you, when using this product:, stop use and ask a doctor, 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
Use
for the treatment of acne.
for the treatment of acne
Purpose
Acne Treatment
Warnings
For external use only
Do Not Use If You
- have very sinsitive skin
- are sensitive to benzoyl peroxide
When Using This Product:
• skin irritation and dryness is 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
• 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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use And Ask A Doctor
if irritation becomes severe.
Keep Out Of Reach Of Children:
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Wet area to be cleaned • apply acne wash and gently massage into damp skin • Wait 1-3 minutes • Rinse thoroughly • Because excessive drying may occur, start with one application daily, then gradually increase to two to three times daily as needed or directed by a doctor • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
Other Information:
store at 20°C - 25°C (68° - 77°F)
Other Information
store at 20°C (68° - 77°F)
Inactive Ingredients:
Water, Sodium C14-16 Olefin Sulfonate, Propylene Glycol, Cocamidopropyl Hydroxysultaine, Glycerin, Acrylates Copolymer, Ceramide NP, Ceramide AP, Ceramide EOP, Niacinamide, Sodium Hyaluronate, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Phenoxyethanol, Sodium Chloride, Sodium Hydroxide, Disodium EDTA, Ethylhexylglycerin
Questions?
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Label copy with drug facts panel
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