The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development Llc for the product Cream (NDC 61354-060). 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 directions, warning, medicinal ingredient, non-medicinal ingredients, keep out of reach of children., otc - purpose, indications & usage, secondary packaging (blister), and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Cleanse skin thoroughly with non-medicated cleanser before applying medication. Apply a thin layer to desired area and gently pat until concealer is blended in. For best results, apply under make-up. Apply 1-3 times daily. If excessive dryness occurs, reduce daily applications, or use as directed by your physician.
For external use only. Use only on non-complex facial acne. Avoid contact with eyes. If contact occurs, immediately flush with water. Do not use with another acne medication, except on the advice of a doctor. If excessive skin irritation develops or increases discontinue use; if irritation persists, consult a doctor.
Salicylic Acid 2% w/w
Octyldodecyl Neopentanoate, Octyldodecanol, Kaolin, Ozokerite, Dipropylene Glycol, Avena Sativa (Oat) Kernel Oil, Hydrogenated Castor Oil, Cetyl Alcohol, Paraffin, Triethoxycaprylylsilane, Phenoxyethanol, Propylparaben, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben. May Contain: Titanium Dioxide, Iron Oxides.
Keep out of reach of children.
Anti-Acne
Use the concealer to help combat existing pimples or prevent new ones from developing.
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