Prosacea Gel
FDA Label NDC 52389-173

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kobayashi Healthcare International, Inc. for the product Prosacea (NDC 52389-173). 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, do not use on, when using this product, otc - stop use, otc - 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

Sulphur 1x (10%)

Purpose

Rosacea/acne treatment

Uses

For the treatment of rosacea, redness, acne and other eruptions of the skin.

Warnings

For external use only

Do Not Use On

  • broken skin
  • large areas of the skin

When Using This Product

  • avoid contact with the eyes
  • apply only to areas with rosacea
  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time.

Otc - Stop Use

Stop use and ask a doctor if skin irritation occurs or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Directions

  • Read all package directions and warnings before use.
  • Use only as directed.
  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer of Prosacea Gel one to three times daily.
  • Massage gently until absorbed into the skin.
  • 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.
  • Intended for use by normally healthy adults only.
  • Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by 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

You may report serious side effects to the phone number provided under Questions? below.

Inactive Ingredients

Acrylates, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylene glycol, propylparaben, tetrasodium EDTA, triethanolamine, water.

Otc - Questions

Questions?  1-800-792-2582

* Please review the disclaimer below.