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Goodbye acne complete treatment gel - Medication Information

Product NDC Code 54031-069
Drug Name

Goodbye acne complete treatment gel

Type Brand
Active Ingredients
Salicylic acid .9638 g/48.19g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 346298
Application Number M006
Labeler Name Peter Thomas Roth, LLC
Packages
Package NDC Code Description
54031-069-01 48.19 g in 1 tube (54031-069-01)
54031-069-02 48.19 g in 1 carton (54031-069-02)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Salicylic Acid 2%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses For the treatment and management of acne. Clears up acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads.

Purpose

Information about the drug product’s indications for use.
Active Ingredient Purpose Salicylic Acid 2%.................................................................Acne treatment

Spl product data elements

Usually a list of ingredients in a drug product.
GOODBYE ACNE Complete treatment gel Salicylic Acid PEG-75 STEARATE COCO-CAPRYLATE/CAPRATE SALICYLIC ACID SALICYLIC ACID ISONONYL ISONONANOATE TETRAHEXYLDECYL ASCORBATE ALCOHOL HONEY POTASSIUM SORBATE DIMETHICONE .ALPHA.-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE CETYL ALCOHOL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE POTASSIUM PHOSPHATE, UNSPECIFIED FORM WATER SORBITAN ISOSTEARATE HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) C9-12 ALKANE SILICON DIOXIDE BUTYLENE GLYCOL POLYSORBATE 20 SHEA BUTTER PENTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL SODIUM HYDROXIDE PHYTATE SODIUM TERT-BUTYL ALCOHOL INDIAN FRANKINCENSE RICE BRAN CAPRYLYL TRISILOXANE CITRIC ACID MONOHYDRATE GLYCERIN DIETHYLHEXYL SYRINGYLIDENEMALONATE RETINOL POLYSORBATE 60 CETETH-20 PEG-100 STEARATE PHENOXYETHANOL AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) STEARETH-20 SQUALANE SODIUM BENZOATE ALOE LECITHIN, SOYBEAN PANTOTHENIC ACID HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
GOODBYE ACNE Complete treatment gel GOODBYE ACNE Complete treatment gel

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children . I f swallowed, get medical help or contact a Poison Control center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll free 1-800-PTR-SKIN (787-7546)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API