Otc - Active Ingredient
Salicylic Acid 3%
Probliva Psoriasis Scalp .spray. Spray
FDA Label NDC 85464-005
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 Psoriasis Scalp .spray. (NDC 85464-005). 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-Psoriasis
Seborrheic Dermatitis / Dandruff
Dosage & Administration
- Controls the symptoms of Psoriasis
- For the relief of the symptoms of scalp itching, irritation, redness, flaking, scaling associated with Psoriasis, Seborrheic Dermatitis and Dandruff
Warnings
For external use only
When usingthis product avoid contact with the eyesIf contact occurs, rinse thoroughly with water
Stop and ask a doctor if condition worsens or does not improve after regular use of this product as directed if condition covers alarge area of the body, consult your doctor before using this product
Do not use
- on broken, irritated, or severely damaged scalp
- if allergic to any ingredients
- on children under 2 years of age unless directed by a doctor
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
- Shake well before use
- Spray directly onto affected areas of the scalp
- Gently massage to ensure evencoverage
- Apply to affected areaas one to four timesdailyor 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
Water, Propanediol, Tromethamine, Butylene Glycol, Peg-40 Hydrogenated Castor Oil, Dipotassium Glycyrrhizate, Panthenol,Aloe Barbadensis Extract,Decyloxazolidinone, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Laurylpyridinium Chloride, Glycerin, 1,2-Hexanediol, Crocus Sativus Flower Extract, Swertia Bimaculata Extract, Avena Sativa (Oat) Kernel Extract, Pullulan,Hydroxyacetophenone, Gentiana Scabra Extract, Gentiana Macrophylla Extract, Allantoin, Lavandula Angustifolia (Lavender) Oil, Citric Acid,Cyclodextrin, Niacinamide, Caffeine, Centella Asiatica Extract, Biotin,Hamamelis Virginiana (Witch Hazel) Extract Rosmarinus Officinalis(Rosemary) Extract
Otc - Questions
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