Dermoneen
FDA Label NDC 43074-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Phillips Company for the product Dermoneen (NDC 43074-111). 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 ingredients, ask doctor, do not use, children, purpose, stop use, when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Drug FactsActive Ingredient            PurposeSalicylic acid  (2%)        Psoriasis medication______________________________________Uses  n Controls the symptoms of psoriasis.______________________________________Warningsn For external use only    n  When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.n Keep away from children    n Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.n May be harmful if swallowed or inhaled______________________________________Ask a physiciann If symptoms last for more than 7 days or clear up and recur within a few days.n If the conditions do not improve.   n Before use on children under 2 years.n Before use if you are allergic to any ingredients listed on this label.n If condition worsens or does not improve after regular use of this product as directed, consult a physician.n If condition covers a large area of the body, consult your physician before using this product.______________________________________Directionsn Clean the skin thoroughly before applying this product.n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.n  Apply to affected areas one times daily or as directed by a physician.  Each morning, cover the entire affected area with a thin layer of this product. Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.  ______________________________________Other information    Store at 40 to 100 degrees F.   Net contents:  3 mL.  This product contains no alcohol; no animal products.               ______________________________________Inactive ingredients   Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid.   ______________________________________Questions and Side effects Use of this product results in no known side effects when used according to directions.  Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;   Tel.  580-746-2430   Email address:  [email protected]

Active Ingredients

Active Ingredient                PurposeSalicylic acid  (2%)        Psoriasis medication

Ask Doctor

Ask a physiciann If symptoms last for more than 7 days or clear up and recur within a few days.n If the conditions do not improve.   n Before use on children under 2 years.n Before use if you are allergic to any ingredients listed on this label.n If condition worsens or does not improve after regular use of this product as directed, consult a physician.n If condition covers a large area of the body, consult your physician before using this product.

Do Not Use

N For external use only    n  When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.n Keep away from children    n Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.n May be harmful if swallowed or inhaledn If condition worsens or does not improve after regular use of this product as directed, consult a physician.n If condition covers a large area of the body, consult your physician before using this product.

Children

 
Keep away from children   
Avoid contact with eyes  
May be harmful if swallowed or inhaled

Purpose

Active Ingredient                PurposeSalicylic acid  (2%)            Psoriasis medication

Stop Use

N When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.

When Using

N For external use only    n  When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.n Keep away from children    n Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.n May be harmful if swallowed or inhaledn Clean the skin thoroughly before applying this product.n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.n  Apply to affected areas one times daily or as directed by a physician.  Each morning, cover the entire affected area with a thin layer of this product. Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.

Warnings

Warningsn For external use only    n  When using this product, skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.n Keep away from children    n Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.n May be harmful if swallowed or inhaled

Dosage & Administration

Directionsn Clean the skin thoroughly before applying this product.n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.n  Apply to affected areas one times daily or as directed by a physician.  n  Each morning, cover the entire affected area with a thin layer of this product. Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.

Use

Uses  n Controls the symptoms of psoriasis.Directionsn Clean the skin thoroughly before applying this product.n Apply product sparingly to one or two small affected areas during the first 3 days.  If no discomfort occurs, follow the directions stated below.n  Apply to affected areas one times daily or as directed by a physician.  n  Each morning, cover the entire affected area with a thin layer of this product. Apply this  product by rubbing it in.  If any liquid remains on the skin (after a 20-second rub-in), you have applied too much product.

Inactive Ingredients

Inactive ingredients   Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid.

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