FDA.reportPublic FDA data

Dr. Gross AB Acne Daily Breakout

Manufacturer
Topiderm, Inc
Effective date
2023-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:54

Label at a glance#

ProductDr. Gross AB Acne Daily Breakout
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

For the treatment of acne Penetrates pores to eliminate most acne blemishes and blackheads Helps prevent development of new acne blemishes and blackheads

Dosage and administration

Clean the skin thoroughly before applying this product Place a cotton ball over the pump firmly and pump 2 to 3 times to saturate, then cover the affected area once 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 or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or e...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Penetrates pores to eliminate most acne blemishes and blackheads
  • Helps prevent development of new acne blemishes and blackheads

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product
  • Place a cotton ball over the pump firmly and pump 2 to 3 times to saturate, then cover the affected area once
  • 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 or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day

Other Information

SPL UNCLASSIFIED SECTION

Sunburn Alert

SPL UNCLASSIFIED SECTION

This product contains alpha hydroxy acid(s) (AHAs) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. We recommend daily use of a sunscreen, whether or not you use this product, to protect your skin from the risks associated with sun exposure.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Alcohol Denat. (SD Alcohol 40-B), Propylene Glycol, Gluconolactone, Polyglyceryl-10 Laurate, Lactic Acid, Pyruvic Acid, Phytic Acid, Azelaic Acid, Salix Alba (Willow) Bark Extract, Carnitine HCl, Xylitol, Caprylic Acid, Leuconostoc/Radish Root Ferment Filtrate, Farnesol, Tetrahydrocurcumin, Chlorhexidine Gluconate, Soy Isoflavones, Saccharide Isomerate, Zinc PCA, Sodium Hyaluronate, Methyl Glucose Sesquistearate, Neopentyl Glycol Diethylhexanoate, PEG-20 Methyl Glucose Sesquistearate, Glyceryl Stearate, Hexylresorcinol, Dimethyl Isosorbide, Propanediol, C13-15 Alkane, Potassium Hydroxide, Stearic Acid, Citric Acid, Calcium Gluconate, Sodium Citrate, Cucumis Sativus (Cucumber) Fruit Water, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

Questions?

OTC - QUESTIONS SECTION

Call 1-888-830-7546

Email clientcare@drdennisgross.com

Monday through Friday, 8:00 AM to 7:00 PM EST

PRINCIPAL DISPLAY PANEL - 150 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Dennis Gross

Alpha Beta®
2% BHA
Breakout Solution

Salicylic Acid
Liquid Acne Treatment

You have: Acne including breakouts,
clogged pores and uneven tone
& texture

You want: All over liquid solution that
exfoliates, clears & prevents acne,
refines pores, evens skin tone and
reduces redness

5.0 fl oz/150ml ℮

PRINCIPAL DISPLAY PANEL - 150 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 150 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251577salicylic acid 2 % Topical SolutionPSN1
251577salicylic acid 20 MG/ML Topical SolutionSCD1
251577salicylic acid 2 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-179-01Dr. Gross AB Acne Daily Breakout1 in 1 BOXLIQUID11
51326-179-01Dr. Gross AB Acne Daily Breakout150 mL in 1 BOTTLELIQUID1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-179DR. GROSS AB ACNE DAILY BREAKOUT (SALICYLIC ACID) LIQUID [TOPIDERM, INC]1Current NDC, 2 package rows20231130_79d7f1f6-d08f-4be0-afc1-9ab4338a954d.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-17951326-179-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
GLUCONOLACTONEWQ29KQ9POTIACT
CARNITINES7UI8SM58AIACT
SALIX ALBA BARK205MXS71H7IACT
FYTIC ACID7IGF0S7R8IIACT
LACTIC ACID, DL-3B8D35Y7S4IACT
PYRUVIC ACID8558G7RUTRIACT
AZELAIC ACIDF2VW3D43YTIACT
ZINC PIDOLATEC32PQ86DH4IACT
ALCOHOL3K9958V90MIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
GENISTEINDH2M523P0HIACT
HEXYLRESORCINOLR9QTB5E82NIACT
TETRAHYDROCURCUMIN .BETA.-O-GLUCURONIDEFA26VP94XRIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
FARNESOLEB41QIU6JLIACT
LEVOCARNITINE HYDROCHLORIDEJ3Y5E6IKS3IACT
HYALURONATE SODIUMYSE9PPT4THIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYL GLUCOSE SESQUISTEARATEV1YW10H14DIACT
PEG-20 METHYL GLUCOSE SESQUISTEARATE0345752X7UIACT
CUCUMBER FRUIT OILR81Y52NPCTIACT
XYLITOLVCQ006KQ1EIACT
CAPRYLIC ACIDOBL58JN025IACT
SODIUM BENZOATEOJ245FE5EUIACT
C13-15 ALKANE114P5I43UJIACT
CALCIUM GLUCONATESQE6VB453KIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
ndc (package): 51326-179-01
ndc (product): 51326-179
ndc11 (package): 51326017901
spl id: c756672e-daa1-4ed1-8834-17c73b23f670
spl set id: 79d7f1f6-d08f-4be0-afc1-9ab4338a954d

Reported adverse events (FAERS/openFDA)#

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