Otc - Active Ingredient
Solubilized Coal Tar Extract 2.00%(Coal Tar 0.5%)
Roycederm Coal Tar Anti Dandruff ,shampoo, Shampoo
FDA Label NDC 85424-032
13 label sections · Submitted to the FDA by Roycederm Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roycederm Llc for the product Roycederm Coal Tar Anti Dandruff , Shampoo, (NDC 85424-032). 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 otc - active ingredient, otc - purpose, dosage & administration, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Andi-dandruff, anti-seborrheic dermatitis, anti-psoriasis
Dosage & Administration
controls the symptom of - dandruff - seborrheic dermatitis - psoriasis.
Warnings
For external use only.
Otc - Ask Doctor
Ask a doctor before using this product if condition covers a large area of the body.
Otc - When Using
- avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
- use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
- do not use for prolonged periods without consulting a doctor.
- do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
- wet hair thoroughly
- massage shampoo into the scalp
- lather, leave on hair & scalp for several minutes.
- rinse and repeat
- for best results use at least twice a week or as directed by a doctor.
Other Safety Information
- store away from direct sunlight
- in rare instances, discoloration of gray, blonde, bleached or tinted hair may occur.
Inactive Ingredient
Water (Aqua), Tea Tree Oil (Melaleuca Alternifolia Leaf Oil), Fleeceflower Root, Cnidium Monnieri, Kochia Scoparia, Gleditsia Sinensis, Typhonium giganteum Eng, Stemona Tuberosa, Rhizoma Smilacis Glabrae, Borneol, Menthol, Fragrance, Cocamide MEA, Citric Acid,
Guar Gum, Ethylene Glycol Stearate.
Otc - Questions
Visit www.roycederm.com
Tel: +(307)461-0958
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Package (Package)
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