Otc - Active Ingredient
Active ingredients Purpose
Salicylic Acid 2% w/w Acne Treatment
Ultra Clear Treatment Lotion
FDA Label NDC 10028-051
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultraceuticals Pty Limited for the product Ultra Clear Treatment (NDC 10028-051). 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, indications & usage, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For treatment of acne
Helps clear acne blemishes and acne pimples
Indications & Usage
Stop use and ask a doctor:
If skin irritation becomes severe.
Otc - Keep Out Of Reach Of Children
When using this product
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water to remove.
Warnings
Warnings
For external use only.
When using this product
Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water to remove.
Dosage & Administration
Directions
- Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily.
- 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 dryness or peeling occurs, reduce application to once a day or every other day.
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Inactive Ingredient
Inactive ingredients
Water/Eau, PPG-15 Stearyl Ether, Arginine, Glycerin, Mandelic Acid, Niacinamide, Tribehenin PEG-20 Esters, Ethoxydiglycol, Methylpropanediol, Cetearyl Alcohol, Disodium Laurimodipropionate Tocopheryl Phosphates, Dimethicone, Bentonite, Caprylyl Glycol, Allantoin, Bisabolol, Hydrated Silica, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6 Xanthan Gum, Disodium EDTA, Phenylpropanol, Eucalyptus Globulus Leaf Oil, Fusanus Spicata Wood Oil, Phenoxyethanol, Eugenia Caryophyllus (Clove) Bud Oil, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, T-Butyl Alcohol, Benzoic Acid, Dehydroacetic Acid.
Package Label.Principal Display Panel
Ultraceuticals
Ultra Clear Treatment Lotion
with Salicylic & Mandelic Acid
Acne Treatment Lotion
50mL / 1.69 fl OZ
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