Active Ingredient
Salicylic Acid.... 0.5%
Mist
FDA Label NDC 61354-092
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development, Llc for the product Mist (NDC 61354-092). 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 active ingredient, purpose, use, warnings, contact with eyes, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Treatment
Use
Use for treatment of acne
Warnings
For external use only
Avoid contact with eyes
Contact With Eyes
Avoid contact with eyes
Otc - When Using
When using this product, skin irritation and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, seek medical help or contact Poison Control right away.
Directions
Use once daily for treatment on clean, dry skin and before serums, moisturizers, and SPF. Recommended for PM use only. To use, mist evenly over your face, neck, and other affected areas.
Inactive Ingredients
Water/Aqua, Sodium Benzoate, Sodium Polyacrylate, Caprylyl/Capryl Glucoside, Potassium Sorbate, Eucalyptus Globulus Leaf Oil, Glycerin, Salix Alba (Willow) Bark Extract, Rosa Damascena Flower Extract, Citric Acid, achillea Milefolium Flower Extract, Glucose, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil.
When Using This Product
When using this product, skin irritation, and dryness is more likely to occur if using more than one topical acne medication at a time. If irritation occurs, limit use to one topical acne medication at a time.
Keep Out Of Reach Of Children
If swallowed, seek medical help or contact Poison Control right away
Secondary Package
61354-092-01_aw (Aw1)
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