Otc - Active Ingredient
Benzalkonium Chloride 0.13%
Salicylic Acid 0.5%
Probliva Antibacterial And Acne Body Wash Shampoo
FDA Label NDC 85464-004
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 Antibacterial And Acne Body Wash (NDC 85464-004). 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 - ask doctor, otc - do not use, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antibacterial
Acne Treatment
Dosage & Administration
- Helps clear up acne blemishes and prevent new breakouts
- Helps reduce bacteria on the skin that can cause acne and body odor
- Gently cleanses and purifies oily or acne-prone skin
Warnings
Fore external use only
Otc - When Using
- Avoid contact with eyes, lips, and mucous membranes. If contact occurs, rinse thoroughly with water
- Skin irritation and dryness are more likely to occur If you use another topical acne medication at the same time
- If irritation occurs, useonly one fopical acne medication at a time
- This product may causemild tingling or temporary dryness in sensitive skin
Otc - Ask Doctor
- Stop and ask a doctor if -Severe irrifation or redness develops
- Condition worsens or does not improve after regular use
Otc - Do Not Use
- On broken skin or open wounds
- lf you are allergic tosalicylic acid or benzalkonium chloride
- Over large areas of the bodyfor extended periods unless directed by a doctor
Indications & Usage
- For use on body only (not for face)
- Apply to wet skin, work into agentle lather, and massage onto affected areas
- Leave on for 30seconds to 1 minute, then rinse thoroughly
- Use once or twice daily,or as directed by a doctor
- If dryness or peeling occurs, reduce frequency of use
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, Sodium Lauroyl Sarcosinate, Cocamidopropyl Betaine, Lauryl Glucoside, Sodium Cocoyl Glycinate, Sodium Lauroamphoacetate,Cocamide Methyl MEA, Disodium Cocoyl Glutamate, Glycerin, Piroctone Olamine, Sodiumn Chloride, Trehalose, Phenoxyethanol, Panthenol,Hamamells Virginiana (Witch Hazel) Water, Aloe Barbadensis Leaf Julce,Diospyros Kaki Fruit Extract, Sodium Benzoate, Menthol, Arginine,Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Arvensis Extract,Lactobacillus/Rice Ferment, Hydrolyzed Oat Protein, Allantoin, Zinc PCA,Citric Acid, Disodium EDTA, Hydrolyzed Sodium Hyaluronate
Otc - Questions
problivabeauty.com
Otc - Keep Out Of Reach Of Children
Keep out of reach of children section.
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