DR. DENNIS GROSS ALPHA BETA ON THE SPOT ELIMINATOR- salicylic acid gel

Dr. Dennis Gross Alpha Beta On the Spot Eliminator by

Drug Labeling and Warnings

Dr. Dennis Gross Alpha Beta On the Spot Eliminator by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc, Topiderm, Inc., Topix Pharmaceuticals, 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.
• 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, then gradually increase to two or three times daily if needed or as directed by a doctor
• If bothersome dryness or peeling occur, 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), Hamamelis Virginiana (Witch Hazel) Water, PVM/MA Decadiene Crosspolymer, Butylene Glycol, Dimethyl Isosorbide, Glycerin, Potassium Hydroxide, Polysorbate 20, Carnitine HCl, Gluconolactone, Phytic Acid, Glycolic Acid, Silybum Marianum Fruit Extract, Bisabolol, Vitex Agnus-Castus Extract, Ganoderma Lucidum (Mushroom) Extract, Vitis Vinifera (Grape) Seed Extract, Tetrahydrocurcumin, Glutathione, Potassium Azeloyl Diglycinate, Farnesol, Leuconostoc/Radish Root Ferment Filtrate, Sodium Pantothenate, Retinol, Niacinamide, Saccharide Isomerate, Ferulic Acid, Camellia Sinensis Leaf Extract, Glyceryl Stearate, Mannitol, sh-Oligopeptide-1, Methyl Glucose Sesquistearate, Neopentyl Glycol Diethylhexanoate, PEG-20 Methyl Glucose Sesquistearate, Aloe Barbadensis Leaf Juice, Centella Asiatica Extract, Phospholipids, Sodium Hyaluronate, Soy Isoflavones, Chamomilla Recutita (Matricaria) Flower Extract, Polyglyceryl-10 Laurate, Zinc PCA, Ethylhexylglycerin, Allantoin, Ethoxydiglycol, Stearic Acid, Citric Acid, Sodium Citrate, Calcium Gluconate, Potassium Gluconate, Cyclodextrin, Tetrasodium Glutamate Diacetate, Caprylic/Capric Triglyceride, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Eugenia Caryophyllus (Clove) Flower Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, 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 - 30 ml Tube Box

Dr Dennis Gross

Alpha Beta®
On The Spot
Eliminator

2% Salicylic Acid
Acne Treatment Gel

You have: Individual pimples,
blemishes, regional breakouts
and inflammation

You want: A fast-acting spot
treatment that reduces pimples,
blackheads & whiteheads while
soothing redness and irritation

1.0 fl oz/30 ml ℮

INGREDIENTS AND APPEARANCE

DR. DENNIS GROSS ALPHA BETA ON THE SPOT ELIMINATOR 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-057
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)
ALCOHOL (UNII: 3K9958V90M)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM HYDROXYCITRATE (UNII: 4586270U1R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARNITINE HYDROCHLORIDE, (+)- (UNII: 11X758JML9)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
FYTIC ACID (UNII: 7IGF0S7R8I)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SILYBUM MARIANUM WHOLE (UNII: JLK089424F)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
VITEX AGNUS-CASTUS LEAF (UNII: W4U9Y3Q5SR)
REISHI (UNII: TKD8LH0X2Z)
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
GLUTATHIONE (UNII: GAN16C9B8O)
POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)
FARNESOL (UNII: EB41QIU6JL)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
SODIUM PANTOTHENATE (UNII: OES0R93F0C)
RETINOL (UNII: G2SH0XKK91)
NIACINAMIDE (UNII: 25X51I8RD4)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
FERULIC ACID (UNII: AVM951ZWST)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MANNITOL (UNII: 3OWL53L36A)
NEPIDERMIN (UNII: TZK30RF92W)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GENISTEIN (UNII: DH2M523P0H)
MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
ZINC PIDOLATE (UNII: C32PQ86DH4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
STEARIC ACID (UNII: 4ELV7Z65AP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
POTASSIUM GLUCONATE (UNII: 12H3K5QKN9)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U)
CLOVE LEAF OIL (UNII: VCA5491KVF)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-057-01	1 in 1 BOX	11/17/2023
1		30 mL in 1 TUBE; 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	11/17/2023

Labeler - Topiderm, Inc (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc		049121643	MANUFACTURE(51326-057)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-057)