Otc - Active Ingredient
Active Ingredients Purpose
Salicylic Acid 0.5% w/w Acne Treatment
Ultra Clear Foaming Cleanser Lotion
FDA Label NDC 10028-050
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 Foaming Cleanser (NDC 10028-050). 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, otc - keep out of reach of children, indications & usage, 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
Clear acne blemishes
Otc - Keep Out Of Reach Of Children
When using this product:
Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water to remove.
If irritation occurs, only use one topical medication
Indications & Usage
Stop use and ask a doctor:
if skin irritation becomes severe
Warnings
Warnings
For External use only.
- 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.
Dosage & Administration
Directions
Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer and rinse thoroughly 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.
Inactive Ingredient
Inactive Ingredients
Water/Eau, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betaine, Sodium Hydroxide, Mandelic Acid, Caprylyl Glycol, Sodium Lauroyl Lactylate, Allantoin, Sodium Chloride, Sodium PCA, Disodium EDTA, Phenylpropanol, Niacinamide, Disodium Lauriminodipropionate Tocopheryl Phosphates, Eucalyptus Globulus Leaf Oil, Fusanus Spicatus Wood Oil, Eugenia Caryophyllus (Clove) Bud Oil, Sodium Benzoate, Benzoic acid, Phenoxyethanol, Dehydroacetic Acid.
Package Label.Principal Display Panel
Ultraceuticals
Ultra Clear Foaming Cleanser
with Mandelic & Salicylic Acid
Acne Face Cleanser
150mL / 5.07 fl. Oz.
* Please review the disclaimer below.
