Otc - Active Ingredient
Selenium Disulfide 1%
Salicy Acid 2%
Probliva Folliculitis .shampoo. Shampoo
FDA Label NDC 85464-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cavtech Holding Llc for the product Probliva Folliculitis .shampoo. (NDC 85464-006). 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 - keep out of reach of children, indications & usage, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Anti-Dandruff / Seborrheic Dermatitis / Psoriasis
Dosage & Administration
- Helps purify clogged follicles and reduce flaking
- Soothes redness, itchiness, and scalp irritation
- Supports a clean, balanced scalp environment
- For relief of Folliculitis, Seborrheic Dermatitis, Psoriasis and Dandruff
Warnings
For external use only
When using this product
- avoid contact with the eyes
- If contact occurs, rinse thoroughly with water.
- condition worsens or does not improve after regular use of this product as directed
- ifcondition cover a large area of the body, consult your doctor before using this product
- on broken, irritated, or severly damaged scalp
- if allergic to any ingredients
- on children under 2 years of age unless dircted by a doctor
Stop and ask a doctor if
Do not use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
- Wet hair and scalp thoroughly
- Massage a small amount into the scalp, leave 2-3 minutes, then rinse
- For best results use at least twice a week or as directed by a doctor
Other Safety Information
- Store at room temperature (15°-30°C/ 59°-86°F)
- Protect from excessive heat and direct sunlight
- Keep out of reach of children
Inactive Ingredient
Aqua, Sodium Laureth Sulfate, Glycerin, Ammonium Lauryl Sulfate,Sodium Lauryl Sulfate, Lauramidopropyl Betaine, Sodium Chloride,Dimethiconol, Phenoxyethanol, Dimethicone, Sodium Hydroxide, Glycol Distearate, Sodium Benzoate, Melaleuca Alternifolia (Tea Tree) Leaf Oil,Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium Lauryl Sulfosuccinate, PEG-150 Pentaerythrityl Tetrastearate,Hydrogenated Castor Oil, Amodimethicone, Polyquaternium-10,Hexadimethrine Chloride, Guar Hydroxypropyltrimonium Chloride,Oleth-8, Etidronic Acid, Cocamidopropyl Betaine, Cocamide Methyl MEA, TEA-Dodecylbenzenesulfonate, Laureth-23, Sodium Sulfate,Polyquaternium-7, Zinc Glycinate, Lauryl Alcohol, Zinc Carbonate, ZincLaurate, Ethylhexylglycerin, Hydrogenated Lecithin
Otc - Questions
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