DR DENNIS GROSS ALL-OVER BLEMISH - salicylic acid gel 
Bentley Laboratories, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

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.

Uses

  • for the treatment and management 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

  • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Directions

  • cleanse skin thoroughly before applying
  • cover the entire affected area AM or PM
  • if bothersome dryness or peeling occurs, reduce application to every other day.

Inactive ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyltrimethylsiloxysilicate Crosspolymer, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ubiquinone, Disodium EDTA, Bisabolol, Menthol, Phenoxyethanol, Farnesol

dr.dennis gross All-Over Blemish Product Label

dr.dennisgross™
SKINCARE

All-Over
Blemish
Solution

Salicylic Acid
Acne Treatment Gel

Pore Minimizer for Sensitive Skin

DERMATOLOGIST APPROVED HYPOALLERGENIC

1.7 fl oz/50mL e

Eliminates and prevents blackheads
Controls oil and shine
Non-drying for sensitive, acne-prone skin

PARABEN FREE

Dr. Dennis Gross Skincare™  LLC.,
Dist. NY, NY 10022
dgskincare.com
MD031521

VEGAN

Bently drgrossAllBlemish1 Label

Bentley drgrossAllBlemish Label

res

DR DENNIS GROSS ALL-OVER BLEMISH  
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE PEG-7 PHOSPHATE (UNII: WTP86Y84TV)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
UBIDECARENONE (UNII: EJ27X76M46)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LEVOMENOL (UNII: 24WE03BX2T)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FARNESOL (UNII: EB41QIU6JL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54111-124-5050 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/200911/28/2022
Labeler - Bentley Laboratories, LLC (068351753)
Registrant - Bentley Laboratories, LLC (068351753)
Establishment
NameAddressID/FEIBusiness Operations
Bentley Laboratories, LLC068351753manufacture(54111-124)

Revised: 11/2022
Document Id: d5eff1e4-c68a-40fd-94ac-7b50479bc3e8
Set id: efdd0974-61bf-454c-9104-58156e80181a
Version: 3
Effective Time: 20221128
 
Bentley Laboratories, LLC