Caring Mill Acne Treatment Cream
FDA Label NDC 81522-951

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. for the product Caring Mill Acne Treatment (NDC 81522-951). 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, use, warnings, when using this product, do not use if you, stop use and ask a doctor if, 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

Use

For the management of acne.

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 timr. If irritation occurs, only use one topical acne medication at a time
  • Avoid unnecessary sun exposure and use sunscreen
  • Avoid contact with the eyes, lips, and mouth. If contact occurs, flush thorughly with water.
  • Avoid contact with hair and dyed products, 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.

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

Directions

  • Clean the skin thoroughly before applying this product
  • Cover the entire affected area 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 applicaiton to once a day or every other day 
  • If going outside, apply sunscreen after using this product. If irritaion or sensitivity develops, stop use of both products and ask a doctor.

Other Information

Protect from excessive heat (104°F/40°C).

Inactive Ingredients

Water, Polyacrylate Crosspolymer-11, Laureth-4, Hydroxypropyl Methylcellulose, Silica, Methicone, Sodium Hydroxide, Disodium EDTA.

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