Active Ingredient
Salicylic Acid
Cream
FDA Label NDC 61354-099
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 Cream (NDC 61354-099). 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, uses, warnings, when using use only, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acne Medication
Uses
Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming
Warnings
For external use only
When Using Use Only
Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer morning and night for best results.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Other Information
Store at 20 - 25C (68-77F)
Inactive Ingredient
Water/Aqua, Propanediol, Glycerin, Caprylic/Capric Triglyceride, Dimethyl Isosorbide, Lactobacillus Ferment, Coconut Alkanes, Coco-Caprylate, Niacinamide, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Tranexamic Acid, Hexyl Laurate, Glycine Soja Soybean, C15-19 Alkane, Potassium Azeloyl Diglycinate, Hydrogenated Polydecene, Glyceryl Stearate, Ceramide NP, Ceramide AP, Bakuchiol, Fucus Spiralis Extract, Rhodomyrtus Tomentosa Fruit Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Acetyl Glucosamine, Hydrolyzed Sodium Hyaluronate, Zinc Sulfate, Melia Azadirachta Leaf Extract, Centella Asiatica Leaf Extract, Silybum Marianum Seed Extract, Vitex Agnus - Castus Extra, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Allantoin, Panthenol, 1,2 - Hexanediol, Sodium Stearoyl Lactylate, Citric Acid, Xanthan Gum, Polyglyceryl - 3 Diisostearate, Polyacrylate Crosspolymer - 6, Coco - Caprylate/Caprate, Caprylhydroxamic Acid, Sodium Phytate, Tocopherol, Sodium Benzoate, Potassium Sorbate, Biosaccaharide Gum - 1, Phenoxyethanol, Sodium Anisate.
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