Label: DERMONEEN- salicylic acid lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 6, 2011

If you are a consumer or patient please visit this version.

  • 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. 
  • Image of product

    Image of product
    Image of product


  • INGREDIENTS AND APPEARANCE
    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