ESSENTIAL BY ARTISTRY ANTI ACNE PORE REFRESHER- salicylic acid gel

Essential by Artistry Anti Acne Pore Refresher by

Drug Labeling and Warnings

Essential by Artistry Anti Acne Pore Refresher by is a Otc medication manufactured, distributed, or labeled by Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

ESSENTIAL BY ARTISTRY ANTI ACNE PORE REFRESHER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-008-01	200 mL in 1 TUBE; Type 0: Not a Combination Product	03/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	03/29/2017

Labeler - Access Business Group LLC (839830713)