GOODBYE ACNE Complete treatment gel

Manufacturer
Peter Thomas Roth, LLC | June Jacobs Labs, LLC
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:00

Label at a glance#

ProductGOODBYE ACNE Complete treatment gel
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Salicylic Acid 2%

OTC - PURPOSE SECTION

Active Ingredient Purpose

Salicylic Acid 2%.................................................................Acne treatment

INDICATIONS & USAGE SECTION

Uses

  • For the treatment and management of acne.
  • Clears up acne blemishes and blackheads.
  • Helps prevent new acne blemishes and blackheads.

WARNINGS SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

Questions or comments?

Call toll free 1-800-PTR-SKIN (787-7546)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOODBYE ACNE Complete treatment gelGOODBYE ACNE Complete treatment gelGOODBYE ACNE Complete treatment gelGOODBYE ACNE Complete treatment gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
346298salicylic acid 2 % Topical GelPSN2
346298salicylic acid 0.02 MG/MG Topical GelSCD2
346298salicylic acid 2 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54031-069-01GOODBYE ACNE Complete treatment gel48.19 g in 1 TUBEGEL48.192
54031-069-02GOODBYE ACNE Complete treatment gel48.19 g in 1 CARTONGEL48.192

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54031-069GOODBYE ACNE COMPLETE TREATMENT GEL (SALICYLIC ACID) GEL [PETER THOMAS ROTH, LLC]2Current NDC, 2 package rows20231115_09b88031-f5fe-8ae1-e063-6394a90a8a6a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54031-06954031-069-01, 54031-069-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
ndc (package): 54031-069-02
ndc (package): 54031-069-01
ndc (product): 54031-069
ndc11 (package): 54031006901
ndc11 (package): 54031006902
spl id: 0a20cdf1-4008-331f-e063-6394a90a04dc
spl set id: 09b88031-f5fe-8ae1-e063-6394a90a8a6a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.