Face Reality 10% Advanced Acne Med Cream
FDA Label NDC 70707-158

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Face Reality for the product Face Reality 10% Advanced Acne Med (NDC 70707-158). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, do not use if you, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

  • For the treatment of acne
  • Penetrates pores to control acne blemishes, blackheads and whiteheads
  • Helps to keep new acne blemishes from forming

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 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, whuch 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.

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

Directions

  • Cleanse the skin thoroughly before applying product. Cover the affected area(s) with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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 produt. If irritation or sensitivity develops, discontinue use of the product and ask a doctor.
  • 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.

Other Information:

  • Store at room temperature of 68-77 F (22-25 C).

Inactive Ingredients:

Water (Aqua), Glycerin, Propanediol, Sodium Hyaluronate, Bisabolol, Carbomer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Ethyhexylglycerin.

Questions Or Comments?

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