GOODBYE ACNE COMPLETE TREATMENT GEL- salicylic acid gel

GOODBYE ACNE Complete treatment gel by

Drug Labeling and Warnings

GOODBYE ACNE Complete treatment gel by is a Otc medication manufactured, distributed, or labeled by Peter Thomas Roth, LLC, June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Salicylic Acid 2%

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.

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

QUESTIONS

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GOODBYE ACNE COMPLETE TREATMENT GEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54031-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.9638 g  in 48.19 g

Inactive Ingredients
Ingredient Name	Strength
PEG-75 STEARATE (UNII: OT38R0N74H)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALCOHOL (UNII: 3K9958V90M)
HONEY (UNII: Y9H1V576FH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
WATER (UNII: 059QF0KO0R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
C9-12 ALKANE (UNII: 7J5R5W72QM)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SHEA BUTTER (UNII: K49155WL9Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHYTATE SODIUM (UNII: 88496G1ERL)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
RICE BRAN (UNII: R60QEP13IC)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
RETINOL (UNII: G2SH0XKK91)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETETH-20 (UNII: I835H2IHHX)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
STEARETH-20 (UNII: L0Q8IK9E08)
SQUALANE (UNII: GW89575KF9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALOE (UNII: V5VD430YW9)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PANTOTHENIC ACID (UNII: 19F5HK2737)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54031-069-01	48.19 g in 1 TUBE; Type 0: Not a Combination Product	06/15/2021
2	NDC: 54031-069-02	48.19 g in 1 CARTON; Type 0: Not a Combination Product	06/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	06/15/2021

Labeler - Peter Thomas Roth, LLC (780458944)

Registrant - June Jacobs Labs, LLC (122610681)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(54031-069)