Prosacea

Alva-Amco Pharmacal Companies, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredients
• Prosacea Uses
• Warnings
• When using this product
• Directions
• Prosacea Other information
• Inactive ingredients

FULL PRESCRIBING INFORMATION

Active ingredients

Sulphur 1x................................Rosacea/acne treatment gel

Prosacea Uses

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

Warnings

For external use only

When using this product

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

Stop use and ask a doctor if excessive skin irritation develops or increases.

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 using.
• Use only as directed.
• Cleanse skin thoroughly before applying medication.
• Cover the entire effective area with a thin layer one to three times daily.
• Massage gently until absorbed into the skin.
• 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 and when using, apply a small amount to a small test patch of affected skin to determine that the medication is well tolerated prior to broader application.
  

Prosacea 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, propylparaben, tetrasodium EDTA, triethanolamine, water.

Questions?  1-800-792-2582

A WORD ABOUT PROSACEA^TM

With your purchase of PROSACEA Gel, you have chosen an effective topical medication that helps diminish symptoms of rosacea, including redness, acne-like bumps and dryness. The PROSACEA moisture-rich formula calms, soothes and conditions dry, reddened and irritated skin. PROSACEA contains no irritating alcohol or petroleum based ingredients. PROSACEA Gel is extremely light, applies easily, is absorbed thoroughly by the skin and has no lingering objectionable odor...you hardly know it's on. With daily use as directed, PROSACEA can help provide visible improvement of your rosacea symptoms.

WHAT IS ROSACEA?

Rosacea is a highly visible skin condition, the exact cause of which is still not fully understood, but thought to have a hereditary component, running in families. Generally, rosacea is characterized by redness of the skin on the cheeks or nose, as well as on the chin or forehead, mostly causing a reddened, inflamed appearance. Rosacea is generally thought to affect those with fair skin, though it can affect all skin types. Symptoms may also include acne-like bumps and visible blood vessels. Rosacea is commonly known to be aggravated by anything that causes a flushing reaction (increased blood-flow) in the skin, which could include alcohol consumption, exposure to sun or extreme temperatures, spicy foods or other irritants. While currently there is no known cure for rosacea, symptoms are known to respond favorably to certain topical treatments. The symptoms of this condition do not typically disappear if left untreated and in some cases can worsen. Symptoms may vary among sufferers with intermittent episodes of symptom improvement and worsening over time. Generally, rosacea progresses through three symptomatic stages:

Stage 1: In the earliest stage of rosacea, the most common symptoms can include subtle to moderate redness, stinging, burning, dryness or tightness of skin. Tiny visible blood vessels (telangiectasia) may also appear on the skin's surface. Skin may begin to react to certain cosmetics, and may also be more reactive to temperature changes or become sensitive to certain foods.

Stage 2: As the condition progresses, redness becomes more persistent. Larger areas of the face may become affected. The formation of papules (red bumps) or pustules (resembling pimples) and swelling may develop. Facial pores and sebaceous follicles may become larger and more prominent.

Stage 3: Generally, stage 3 rosacea is less common, but individuals diagnosed with this advanced stage of rosacea exhibit all characteristics of stages 1 and 2. Facial features may become thicker, irregular or even exhibit gradual deformation. Affected areas of the skin become a deeper shade of red. The sebaceous glands may be extremely enlarged, contributing to further redness, inflammation, papules, pustules and swelling of facial features. If you believe you may have rosacea, do not delay in consulting a doctor for proper diagnosis and advice.

SUGGESTIONS FOR HOW TO AVOID AND CONTROL FLARE-UPS:

Medical experts have suggested some ways to avoid aggravating symptoms which include:

• Avoid direct sunlight as rosacea symptoms can be triggered or worsened by exposure to sunlight. When in the sun, use a mild sunscreen.
• Avoid rubbing or scrubbing affected areas, which can irritate the skin or stimulate increased blood flow to the areas.
• Use mild soaps, moisturizers and sunscreens and be sure to gently apply them to the face in order to avoid irritating affected areas.
• Avoid hot drinks, spicy foods and alcoholic beverages that can cause flushing.
• Protect your skin from extreme hot and cold conditions.
• Avoid cosmetics, soaps, and other facial products that contain ingredients such as alcohol, menthol and fragrances.
• Keep a log of any products, medicines, foods or weather and/or environmental conditions that may trigger flushing episodes or symptom flare-ups in order to avoid them in the future.
• Consult your doctor for treatment recommendations.

SOME ADDITIONAL SUGGESTIONS FOR OVERALL GOOD SKIN HEALTH:

• Get adequate rest
• Avoid emotional stress where possible
• Avoid excessive/stressful exercise which might cause skin flushing
• Drink adequate amounts of water daily
  
• Keep hands and face clean
• Keep affected areas clean and well moisturized
• Shampoo hair regularly using a mild antibacterial shampoo
• Avoid touching affected areas

HOW CAN PROSACEA ^TM GEL HELP?

PROSACEA contains sulphur 1x, a medically recognized homeopathic ingredient that has been recognized for relief of common rosacea symptoms such as redness, bumps, and dryness, when used as directed. PROSACEA's non-oily formula is non-comedogenic (doesn't cause pimples) and won't clog pores or irritate sensitive skin. It is important for successful results that once treatment is started with PROSACEA, it is continued uninterrupted, carefully following and adhering to package directions until satisfactory results are achieved or with further advice from a doctor.

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

Warnings: For external use only.

When using this product avoid contact with the eyes. Using other topical acne medications at the same time or immediately after this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor if excessive skin irritation develops or increases.

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 using. Use only as directed. Cleanse skin thoroughly, and pat dry before applying medication. Cover the entire affected area with a thin layer one to three times daily. Massage gently until absorbed into the skin. Intended for use by normally healthy adults only. Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.

Other Information: Serious side effects associated with the use of this product may be reported to the phone number provided below.

Inactive ingredients: Acrylates, aloe barbadensis leaf juice, diazolidinyl urea, lactose, methylparaben, propylparaben, tetrasodium EDTA, triethanolamine, water.

How Supplied: Net wt 0.75 oz. tube

Storage: Keep tightly closed when not in use. Store away from excessive heat or cold.

Questions? 1-800-792-2582