Acne Treatment Lotion
FDA Label NDC 67226-2050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vivier Pharma, Inc. for the product Acne Treatment (NDC 67226-2050). 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 skintx acne treatment lotion benzoyl peroxide lotion usp 5%, active ingredient, purpose, use, warnings, ask a doctor before use if you are, keep out of reach of children., do not use if you, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Skintx Acne Treatment Lotion Benzoyl Peroxide Lotion Usp 5%


Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Treatment

Use

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Warnings

For external use only

Ask A Doctor Before Use If You Are

  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.  If this occurs, only one medication should be used unless directed by a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do Not Use If You

  • have very sensitive skin.
  • are sensitive to Benzoyl Peroxide.

When Using This Product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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 oncentration.

Stop Use And Ask A Doctor If

  • irritation becomes severe.

Directions

  • Wash hands with a non-medicated soap (contains no Benzoyl Peroxide).
  • Cleanse and dry face thoroughly 5 minutes before use.
  • Using fingertips apply evenly to affected areas.
  • Use both morning and night or as directed by a physician.
  • If dryness or peeling occurs, reduce application to once a day or every other day.
  • Fair- skinned individuals should begin with one application.
  • For more severe cases, and/or if substantial improvement is not apparent within 3 to 4 weeks, consult a health care practitioner.

Inactive Ingredients

C13-14 Isoparaffin, Ethylhexylglycerin, Lanolin Oil, Laureth-4, Laureth-7, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Water/Eau, Xanthan Gum.

Other Information

  •  store at room temperature (59-86°F / 15-30°C)

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