Otc - Active Ingredient
Active Ingredient
Salicylic Acid 2%
Goodbye Acne Complete Treatment Gel
FDA Label NDC 54031-069
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Peter Thomas Roth, Llc for the product Goodbye Acne Complete Treatment Gel (NDC 54031-069). 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, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Active Ingredient Purpose
Salicylic Acid 2%.................................................................Acne treatment
Indications & Usage
Uses
- For the treatment and management of acne.
- Clears up acne blemishes and blackheads.
- Helps prevent new acne blemishes and blackheads.
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 eyes. If contact occurs, flush thoroughly with water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.
Dosage & Administration
Directions
- Cleanse 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, the gradually increase to two to three times daily if needed or as direrected by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Inactive Ingredient
Inactive Ingredients
Water/Aqua/Eau, Isononyl Isononanoate, Pentylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Propanediol, Glyceryl Stearate, C9-12 Alkane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Caprylyl Methicone, Phenoxyethanol,Polyacrylate Crosspolymer-6, Sodium Hydroxide, PEG-75 Stearate, PEG-100 Stearate, Tocopheryl Acetate, Silica, Glycerin, Butylene Glycol, Ceteth-20, Steareth-20, Citric Acid, Lecithin, Coco-Caprylate/Caprate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Phytate, Phospholipids, Tetrahexyldecyl Ascorbate, Diethylhexyl Syringylidenemalonate, Squalane,Sodium Benzoate, Alcohol, Retinol, Polysorbate 20, Leuconostoc/Radish Root Ferment Filtrate, Potassium Sorbate, Polysorbate 60, t-Butyl Alcohol, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Extract, Honey Extract, Potassium Phosphate, Pantothenic Acid, Sorbitan Isostearate, Aloe Barbadensis Extract, Hydrolyzed Vegetable Protein
Otc - Questions
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