Label: DERMONEEN- salicylic acid lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 43074-111-21, 43074-111-22 - Packager: Phillips Company
- 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.
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- Official Label (Printer Friendly)
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DRUG FACTS
Drug Facts
Active Ingredient Purpose
Salicylic acid (2%) Psoriasis medication
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Uses
n Controls the symptoms of psoriasis.
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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
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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.
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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.
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Other information
Store at 40 to 100 degrees F. Net contents: 3 mL. This product contains no alcohol; no animal products.
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Inactive ingredients
Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid.
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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
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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.
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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
- PURPOSE
- STOP USE
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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.
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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
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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.
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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
- Image of product
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INGREDIENTS AND APPEARANCE
DERMONEEN
salicylic acid lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43074-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.02 mL in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43074-111-22 1 in 1 BOX 1 NDC:43074-111-21 3 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/06/2011 Labeler - Phillips Company (612368238) Establishment Name Address ID/FEI Business Operations Phillips Company 612368238 manufacture