The following Structured Product Label (SPL) was submitted to the FDA by Albra Dewyn Llc for the product Skin And Scalp Body (NDC 59151-646). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding uses, warnings, directions, other information, inactive ingredients, question or comments, drug fact, label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Controls symptoms of psoriasis, Atopic & Seborrheic Dermatitis & Dandruff.
Relieves itching, flaking, scaling & scalp irritation.
controls symptoms of:
For external use only:
Ask a doctor before use if your body has a condition that which convers a large part of the body. Keep out of reach of children. when using this product: do not use for a prolonged period of time without consulting a doctor. Do not use with other forms of psoriasis therapy such as ultrviolet radiation or prescription drugs unless directed by a doctor. Avoid contact with eyes. if contact occurs, rinse eys thoroughly with water. Use cation in exposing skin to sunlght after applying this product. It may increase your tendecy to sunburn for up to 24 hours after application. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.
Shake well, for best result use twice daily or directed by doctor.
In rare instances, discoloratin of gray, blonde, bleached or tinted hair may occur.
Purified water, glycerin (from coconut oil), stearic acid (from coconut oil), pure plant oil complex (soy & jojoba oils), cetylpalmitate (from palm oil), eucalyptus oil, cetearyl alcohol (from palm oil), poly sorbate (from palm oil), glyceryl stearate (from vegetable sources), cetyl alcohol (from palm oil), aminodimethicone (from silica), phenoxyethanol and ethylhexylglycerin (preservative complex from plant source), camphor, menthol, methylparaben, benzoic acid, propylparaben, PEG 150 distearate, vitamin E acetate (DL-alpha-tocopheryl acetate), vitamin A palmitate (Retinyl Palmitate), vitamin H (biotin), polysorbate 80, citric acid.
Toll free number: 1-855-458-2400, Fax: 1-972-228-2400 or [email protected]
Active Ingredients Purpose
Coal tar solution 1.7% v/v..........................................................................Psoriasis, Atopic & seborrheic
(equivalent to 0.5% coal tar)...................................................................................Dermatitis & Dandruff
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