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urea aerosol, foam
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For softening, smoothing and removing rough scaling hyperkeratotic skin
KERAFOAM® 42 Emollient Foam is a keratolytic emollient
foam which is a tissue softener for skin and/or nails. Each gram of KERAFOAM 42
Emollient Foam contains 42% urea USP, ceteareth-10 phosphate, cetearyl alcohol
NF, dicetyl phosphate, dl-alpha tocopheryl acetate USP, edetate disodium dihydrate
USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP,
sodium phosphate monobasic USP. Also contains: Propellant HFA-134a (1,1,1,2-
Urea gently lyses/dissolves the intercellular matrix of surface skin cells loosening and allowing a shedding of rough, thickened and scaly hyperkeratotic skin. Urea also moisturizes and softens skin.
For softening, smoothing and removing rough scaling hyperkeratotic skin in conditions such as xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
Known hypersensitivity to any of the listed ingredients. Discontinue use if hypersensitivity is observed.
FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).
Information for patients:
This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.
Pregnancy Category C. Animal reproduction studies have not been conducted with KERAFOAM 42 Emollient Foam. It is not known whether KERAFOAM 42 Emollient Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. KERAFOAM 42 Emollient Foam should be given to a pregnant woman only if clearly needed.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when KERAFOAM 42 Emollient Foam is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTRATION
Shake Vigorously, Tap Bottom of Can, and Prime Before
Initial Use. Shake Vigorously and Tap Before Each Use.
KERAFOAM 42 Emollient Foam is supplied in a 60 g (NDC# 16781-181-60) and 100g (NDC# 16781-181-96) aluminum cans.
Store at room temperature: 59º - 77ºF (15º - 25ºC). Protect from freezing. Store upright.
P/N 2614 Rev. 1
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Kerafoam42-Outer Box - 5g
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Kerafoam42-Inner Label - 5g
Revised: 06/2011 Onset Dermatologics LLC
Reproduced with permission of U.S. National Library of Medicine
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