Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 51b97443-5764-44c9-a2a8-cd1bc01b2c66
Route
TOPICAL
Published
Effective Date 2011-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 mL)
Inactive Ingredients
Dimethyl Sulfoxide Ascorbic Acid Dipropylene Glycol Water Sorbic Acid Magnesium Stearate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-01-06

Description

Drug Facts Active Ingredient            Purpose Salicylic acid  (2%)        Psoriasis medication ______________________________________ Uses  n Controls the symptoms of psoriasis. ______________________________________ Warnings 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 inhaled ______________________________________ Ask a physician n 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. ______________________________________ Directions n 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]

Purpose

Active Ingredient                Purpose Salicylic acid  (2%)            Psoriasis medication


Medication Information

Purpose
Active Ingredient                Purpose

Salicylic acid  (2%)            Psoriasis medication

Description

Drug Facts Active Ingredient            Purpose Salicylic acid  (2%)        Psoriasis medication ______________________________________ Uses  n Controls the symptoms of psoriasis. ______________________________________ Warnings 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 inhaled ______________________________________ Ask a physician n 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. ______________________________________ Directions n 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]

Use
Uses 

n Controls the symptoms of psoriasis.



Directions

n 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.

Children

 

Keep away from children   

Avoid contact with eyes  

May be harmful if swallowed or inhaled

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.



Warnings
Warnings

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 inhaled

Ask Doctor
Ask a physician

n 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 inhaled

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.



Drug Facts
Drug Facts

Active Ingredient            Purpose

Salicylic acid  (2%)        Psoriasis medication

______________________________________

Uses 

n Controls the symptoms of psoriasis.

______________________________________

Warnings

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 inhaled

______________________________________

Ask a physician

n 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.

______________________________________

Directions

n 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]

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 inhaled

n 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.

Image of Product
Image of product





Active Ingredients


Active Ingredient                Purpose

Salicylic acid  (2%)        Psoriasis medication



Inactive Ingredients
Inactive ingredients  

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

Dosage & Administration
Directions

n 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.


Structured Label Content

Use (USE)
Uses 

n Controls the symptoms of psoriasis.



Directions

n 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.

Purpose (PURPOSE)
Active Ingredient                Purpose

Salicylic acid  (2%)            Psoriasis medication

Children (CHILDREN)

 

Keep away from children   

Avoid contact with eyes  

May be harmful if swallowed or inhaled

Stop Use (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.



Warnings (WARNINGS)
Warnings

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 inhaled

Ask Doctor (ASK DOCTOR)
Ask a physician

n 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 (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 inhaled

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.



Drug Facts (DRUG FACTS)
Drug Facts

Active Ingredient            Purpose

Salicylic acid  (2%)        Psoriasis medication

______________________________________

Uses 

n Controls the symptoms of psoriasis.

______________________________________

Warnings

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 inhaled

______________________________________

Ask a physician

n 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.

______________________________________

Directions

n 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]

When Using (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 inhaled

n 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.

Image of Product (Image of product)
Image of product





Active Ingredients (ACTIVE INGREDIENTS)


Active Ingredient                Purpose

Salicylic acid  (2%)        Psoriasis medication



Inactive Ingredients (INACTIVE INGREDIENTS)
Inactive ingredients  

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

Dosage & Administration (DOSAGE & ADMINISTRATION)
Directions

n 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.


Advanced Ingredient Data


Raw Label Data

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