Otc - Active Ingredient
Salicylic Acid 1%
Probliva Acne Clarifying Body Wash Gel
FDA Label NDC 85464-010
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 Acne Clarifying Body Wash (NDC 85464-010). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Acne treatment
Dosage & Administration
- for the treatment of acne
- helps clear acne blemishes
- helps prevent new acne blemishes from forming
Warnings
For external use only
Otc - When Using
skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, noly use one topical acne medication at a time avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation becomes severe.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
- wet affected area
- apply product to hands or washcloth and work into a lather
- cleanse affected area thoroughly
- rinse well
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Safety Information
- Store at 20°-25°C (68°-77°F)
- excursions permitted between 15°-30°C (59°-86°F)
- protec tfrom excessive heat and direct sunlight
Inactive Ingredient
Water, Sodium Laureth Sulfate, Sodium Lauroamphoacetate,Sodium Chloride, Lauramidopropyl Betaine, Aloe Barbadensis Leaf Juice, Decyl Glucoside, Centella Asiatica Extract,Maltooligosyl Glucoside, Sodium Benzoate, Phenoxyethanol,Hydrogenated Starch Hydrolysate, Sodium Citrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Kernelamide DEA, LacticAcid, Michelia Alba Flower Oil, Niacinamide, Panthenol,Allantoin, Gluconolactone, Glycerin, Camellia Sinensis Leaf Extract, Sodium Lauroyl Sarcosinate, Sarcosine, Zinc PCA,Glycine, Glutamic Acid, Aspartic Acid
Otc - Questions
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