DR. GROSS AB ACNE DAILY BREAKOUT- salicylic acid liquid

Dr. Gross AB Acne Daily Breakout by

Drug Labeling and Warnings

Dr. Gross AB Acne Daily Breakout by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

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

Warnings

For external use only

When using this product

• 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.

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

Directions

• 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

Sunburn Alert

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

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?

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

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 ℮

INGREDIENTS AND APPEARANCE

DR. GROSS AB ACNE DAILY BREAKOUT 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-179
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
CARNITINE (UNII: S7UI8SM58A)
SALIX ALBA BARK (UNII: 205MXS71H7)
FYTIC ACID (UNII: 7IGF0S7R8I)
LACTIC ACID, DL- (UNII: 3B8D35Y7S4)
PYRUVIC ACID (UNII: 8558G7RUTR)
AZELAIC ACID (UNII: F2VW3D43YT)
ZINC PIDOLATE (UNII: C32PQ86DH4)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GENISTEIN (UNII: DH2M523P0H)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
TETRAHYDROCURCUMIN .BETA.-O-GLUCURONIDE (UNII: FA26VP94XR)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
FARNESOL (UNII: EB41QIU6JL)
LEVOCARNITINE HYDROCHLORIDE (UNII: J3Y5E6IKS3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)
XYLITOL (UNII: VCQ006KQ1E)
CAPRYLIC ACID (UNII: OBL58JN025)
SODIUM BENZOATE (UNII: OJ245FE5EU)
C13-15 ALKANE (UNII: 114P5I43UJ)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-179-01	1 in 1 BOX	11/10/2023
1		150 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	11/10/2023

Labeler - Topiderm, Inc (049121643)