DERMONEEN - salicylic acid lotion 
Phillips Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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:  hp@valliant.net

ACTIVE INGREDIENTS


Active Ingredient                Purpose
Salicylic acid  (2%)        Psoriasis medication

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.

CHILDREN

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

PURPOSE

Active Ingredient                Purpose
Salicylic 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 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.

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

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.

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.

INACTIVE INGREDIENTS

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

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DERMONEEN 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.02 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
dimethyl sulfoxide (UNII: YOW8V9698H)  
ascorbic acid (UNII: PQ6CK8PD0R)  
dipropylene glycol (UNII: E107L85C40)  
water (UNII: 059QF0KO0R)  
sorbic acid (UNII: X045WJ989B)  
magnesium stearate (UNII: 70097M6I30)  
stearic acid (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43074-111-221 in 1 BOX
1NDC:43074-111-213 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/06/2011
Labeler - Phillips Company (612368238)
Establishment
NameAddressID/FEIBusiness Operations
Phillips Company612368238manufacture

Revised: 1/2011
Document Id: 50d6fcb2-68f1-4fa4-8f50-93b80a53e2e9
Set id: 51b97443-5764-44c9-a2a8-cd1bc01b2c66
Version: 1
Effective Time: 20110106
 
Phillips Company