Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask Paste
FDA Label NDC 52261-7301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosco International, Inc. for the product Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask (NDC 52261-7301). 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, use, warnings, do not use if you, ask doctor before use, when using this product, 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

Active Ingredient/Purpose

Benzoyl Peroxide............Acne Treatment

Use

For the treatment of acne

Warnings

For external use only

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Ask Doctor Before Use

if you have redness over the affected area

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

  • Clean the skin throughly before applying this product
  • Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly.
  • Use once a day or as directed by a doctor.
  • If dryness or peeling occurs, reduce application to once every other day.
  • If going outside, apply sunscreen after using this product.
  • If irritation or sensitivity develops, discontinue use and consult a doctor.

Other Information

Store at room temperature 20°-25°C (68°-77°F)

Protect from heat and direct sunlight.

Inactive Ingredients

Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Glycolic Acid, Niacinamide, Panthenol, Phenoxyethanol, Ethylhexylglycerin,  Hydroxyethylcellulose, Carbomer, Xanthan Gum, Tocopheryl Acetate, Sodium Hydroxide

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