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  5. Label Information: Prosacea

FDA Label for Prosacea

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE ON
    6. WHEN USING THIS PRODUCT
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prosacea Product Label

The following document was submitted to the FDA by the labeler of this product Alva-amco Pharmacal Companies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.