Active Ingredient
Benzoyl Peroxide 5.00%
Naturium Benzoyl Peroxide Cleanser 5% Cream
FDA Label NDC 76354-123
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by E.l.f. Cosmetics, Inc for the product Naturium Benzoyl Peroxide Cleanser 5% (NDC 76354-123). 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, uses, warnings, when using this product, do not use if you, stop use and ask a doctor if, 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
Acne Treatment
Uses
- Helps fight existing acne breakouts and prevents future acne breakouts.
Warnings
For external use only.
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.
Do Not Use If You
- have very sensitive skin
- are sensitive to benzoyl peroxide
Stop Use And Ask A Doctor If
- irritation becomes severe
Keep Out Of Reach Of Children.
Keep out of reach of children.
Directions
Shake Well.
- gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area.
- cover the entire affected area and rinse thoroughly.
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or two 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.
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above. Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.
Inactive Ingredients
Aqua (Water), Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Glycerin, Cocamidopropyl Hydroxysultaine, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Sodium Methyl Cocoyl Taurate, Xylitol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Benzoate, Sodium Phosphate, Sodium Citrate, Propanediol, Diethylhexyl Sodium Sulfosuccinate, Carbomer, Sodium Hydroxide.
Product Packaging
1 (76354 123)
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