Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID ca63dce1-825a-4338-9c72-77d5bc8a7661
Route
TOPICAL
Published
Effective Date 2010-12-30
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 2010-12-30

Description

Drug Facts Active Ingredient               Purpose Salicylic acid  (2%)           Acne medication ______________________________________ Uses  n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal. ______________________________________ 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 eyes   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. ______________________________________ 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 Each morning, cover the entire affected area with a thin layer of this product. n 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%)           Acne medication ______________________________________ Uses  n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.


Medication Information

Purpose
Active Ingredient               Purpose

Salicylic acid  (2%)           Acne medication

______________________________________

Uses 

n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

Description

Drug Facts Active Ingredient               Purpose Salicylic acid  (2%)           Acne medication ______________________________________ Uses  n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal. ______________________________________ 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 eyes   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. ______________________________________ 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 Each morning, cover the entire affected area with a thin layer of this product. n 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 Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

______________________________________



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 Each morning, cover the entire affected area with a thin layer of this product (ACNE22).

n 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 eyes  

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.





Do Not 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.

n Keep away from children   

n Avoid contact with eyes  

n May be harmful if swallowed or inhaled

Drug Facts
Drug Facts

Active Ingredient               Purpose

Salicylic acid  (2%)           Acne medication

______________________________________

Uses 

n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

______________________________________

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 eyes  

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.

______________________________________

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 Each morning, cover the entire affected area with a thin layer of this product.

n 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



For external use only   

Avoid contact with eyes  

May be harmful if swallowed or inhaled

If symptoms last for more than 7 days or clear up and recur within a few days.

If the conditions do not improve.  

Store at 40 to 120 degrees F.

Image of Product
Image of product





Active Ingredients
Active Ingredient               Purpose

Salicylic acid  (2%)           Acne medication



Inactive Ingredients
Inactive ingredients  

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

Dosage & Administration
Uses 

n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

______________________________________



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 Each morning, cover the entire affected area with a thin layer of this product.

n 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 Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

______________________________________



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 Each morning, cover the entire affected area with a thin layer of this product (ACNE22).

n 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%)           Acne medication

______________________________________

Uses 

n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

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 eyes  

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.





Do Not Use (DO NOT 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.

n Keep away from children   

n Avoid contact with eyes  

n May be harmful if swallowed or inhaled

Drug Facts (DRUG FACTS)
Drug Facts

Active Ingredient               Purpose

Salicylic acid  (2%)           Acne medication

______________________________________

Uses 

n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

______________________________________

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 eyes  

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.

______________________________________

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 Each morning, cover the entire affected area with a thin layer of this product.

n 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)



For external use only   

Avoid contact with eyes  

May be harmful if swallowed or inhaled

If symptoms last for more than 7 days or clear up and recur within a few days.

If the conditions do not improve.  

Store at 40 to 120 degrees F.

Image of Product (Image of product)
Image of product





Active Ingredients (ACTIVE INGREDIENTS)
Active Ingredient               Purpose

Salicylic acid  (2%)           Acne medication



Inactive Ingredients (INACTIVE INGREDIENTS)
Inactive ingredients  

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

Dosage & Administration (DOSAGE & ADMINISTRATION)
Uses 

n Acne medication lotion.  For the treatment of acne.  Clears up most acne blemishes and allows skin to heal.

______________________________________



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 Each morning, cover the entire affected area with a thin layer of this product.

n 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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