Drug labels

Prosacea

SULPHUR · Kobayashi Healthcare International, Inc. · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
e5907672-3ee1-44d3-9c92-6345ad3f4238
ID
55179acd-293a-7e75-e063-6294a90a23fa
Effective time
20261030
Version
12
SPL product data elements

Prosacea Sulphur SODIUM HYDROXIDE WATER EDETATE SODIUM PHENOXYETHANOL ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) LACTOSE SULFUR SULFUR ALOE VERA LEAF

Active ingredient
Active ingredient Sulphur 1x (10%)
Purpose
Purpose Rosacea/acne treatment
Indications and usage
Uses For the treatment of rosacea, redness, acne and other eruptions of the skin.
Warnings
Warnings For external use only
Do not use
Do not use on broken skin large areas of the skin
When using

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.

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

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.

Information for patients
Other information You may report serious side effects to the phone number provided under Questions? below.
Inactive ingredient

Inactive ingredients Acrylates/C10-30 alkyl acrylate cosspolymer, aloe barbadensis leaf juice, lactose, phenoxyethanol, purified water, sodium hydoxide, tetrasodium EDTA.

Questions
Questions? 1-800-792-2582
SPL patient package insert

Dermatologist Recommended PROSACEA ® Medicated Rosacea Gel Heal, Don't Conceal TM , Your Rosacea Symptoms Control Rosacea Symptoms: Redness, Pimples, Irritation and See Visible Results in Just Days WHAT IS ROSACEA? Rosacea is a condition that is characterized by persistent redness and inflammation of the skin on the cheeks, nose, chin or forehead. 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, including alcohol consumption, exposure to sun or extreme temperatures, spicy foods or other irritants. Rosacea symptoms 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 Shampoo hair regularly using a mild antibacterial shampoo Avoid touching affected areas Use a broad-spectrum, SPF 25+ sunscreen and mild moisturizer daily HOW PROSACEA ® GEL CAN 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 irritation, when used as directed. PROSACEA 's non-oily formula is non-comedogenic (doesn't cause pimples) and won't clog pores. 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 given further advice from a doctor. For Best Results: After applying Prosacea Gel to your face, let it absorb fully into your skin before applying your moisturizer or sunscreen. www.Prosacea.com No Gluten Ingredients

Package label principal display panel
PDP
Harmonized identifiers (openFDA)
Brand name
Prosacea
Generic name
SULPHUR
Manufacturer name
Kobayashi Healthcare International, Inc.
Product NDC
52389-173
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
SULFUR
SPL ID
55179acd-293a-7e75-e063-6294a90a23fa
SPL set ID
e5907672-3ee1-44d3-9c92-6345ad3f4238
Package NDC
52389-173-01, 52389-173-21, 52389-173-42
Is original packager
true
UNII
70FD1KFU70
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.