ESSENTIAL BY ARTISTRY ANTI ACNE PORE REFRESHER- salicylic acid gel 
Access Business Group 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.

----------

Essential by Artistry Anti Acne Pore Refresher

Drug Facts

Active Ingredient

Salicylic Acid 0.5% (W/W P/P)

Purpose

Acne Treatment

Use

  • For the treatment of acne.

Warnings

Keep out of reach of children.

  • If swallowed, get medical help  or contact a poison control center right away.
  • For external use only.
  • Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a doctor/ health care practitioner.
  • Avoid contact with eyes; if contact occurs, rinse thoroughly with water. Discontinue use if excessive skin irritation develops or increases. If irritation persists, consult a doctor/health care practitioner.

Directions

  • Cleanse the skin thoroughly before applying product. Lightly soak a cotton pad and apply to the entire affected area with a thin layer one to two times daily, or as directed by a health care  practitioner. Follow with lotion.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times daily if needed or as directed by a doctor/health care practitioner.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

WATER, ALCOHOL DENAT., GLYCERIN, METHYL GLUCETH-20, ALOE BARBADENSIS LEAF JUICE, ISOCETETH-20, ZINC PCA, SODIUM CITRATE, PROPYLENE GLYCOL, ARGININE, ALCOHOL, ISOPROPYL ALCOHOL, BUTYLENE GLYCOL, ALLANTOIN, DIPOTASSIUM GLYCYRRHIZATE, PANTHENOL, SALIX ALBA (WILLOW) BARK EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) BARK/TWIG EXTRACT, BENZOIC ACID, FRAGRANCE/PARFUM, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, BISABOLOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, CITRUS LIMON (LEMON) FRUIT EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, SPIRAEA ULMARIA EXTRACT, POTASSIUM SORBATE, SODIUM BENZOATE, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, SORBITOL, PHENOXYETHANOL, ETHYLPARABEN,
METHYLPARABEN, PROPYLPARABEN, ASCORBIC ACID, CAMELLIA SINENSIS LEAF EXTRACT, SODIUM HYDROXIDE, CITRIC ACID

Package Labeling:

Label

ESSENTIAL BY ARTISTRY ANTI ACNE PORE REFRESHER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ISOCETETH-20 (UNII: O020065R7Z)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARGININE (UNII: 94ZLA3W45F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALLANTOIN (UNII: 344S277G0Z)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PANTHENOL (UNII: WV9CM0O67Z)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)  
ACEROLA (UNII: XDD2WEC9L5)  
LEVOMENOL (UNII: 24WE03BX2T)  
CHAMOMILE (UNII: FGL3685T2X)  
LEMON (UNII: 24RS0A988O)  
CUCUMBER (UNII: YY7C30VXJT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GINGER (UNII: C5529G5JPQ)  
SORBITOL (UNII: 506T60A25R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-008-01200 mL in 1 TUBE; Type 0: Not a Combination Product03/29/201708/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/29/201708/01/2020
Labeler - Access Business Group LLC (839830713)

Revised: 11/2020
 
Access Business Group LLC