ESSENTIAL BY ARTISTRY ANTI ACNE TREATMENT- salicylic acid gel

Essential By Artistry Anti Acne Treatment by

Drug Labeling and Warnings

Essential By Artistry Anti Acne Treatment 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 Ingredients

Salicylic Acid 1.0% (W/W P/P)

Purpose

Acne Treatment

Uses

• For the treatment of acne.

Warnings

For external use only.

Keep out of reach of children.

• If swallowed, get  medical help or contact a poison control center right away.
• 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

Directions

• Cleanse the skin thoroughly before applying product. Cover the entire affected area with a thin layer one to three times daily, or as directed by a health care practitioner.
• 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., BUTYLENE GLYCOL, GLYCERIN, DIMETHICONE, CYCLOPENTASILOXANE, POLYACRYLAMIDE, PEG-8, ALOE BARBADENSIS LEAF JUICE, TRIETHANOLAMINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, POLYSILICONE-11, C13-14 ISOPARAFFIN, ZINC PCA, BISABOLOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, ISOPROPYL ALCOHOL, ALCOHOL, BENZYL ALCOHOL, DIPOTASSIUM GLYCYRRHIZATE, PROPYLENE GLYCOL, CUCUMIS SATIVUS (CUCUMBER)
FRUIT EXTRACT, CITRUS LIMON (LEMON) FRUIT EXTRACT, SODIUM CITRATE, LAURETH-7, ALLANTOIN, DISODIUM EDTA, SALIX ALBA (WILLOW) BARK EXTRACT, SORBITOL, HAMAMELIS VIRGINIANA (WITCH HAZEL) BARK/TWIG EXTRACT, POLYSORBATE 60, AMMONIUM POLYLACRYLOYLDIMETHYL TAURATE, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, TOCOPHERYL ACETATE, CHAMOMILLA RECUTITA
MATRICARIA) FLOWER EXTRACT, POLYSORBATE 80, SORBITAN ISOSTEARATE, SPIRAEA ULMARIA EXTRACT, POLYSORBATE 20, PHENOXYETHANOL, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, ASCORBIC ACID, POTASSIUM SORBATE, CAMELLIA SINENSIS LEAF EXTRACT, ETHYLPARABEN, METHYLPARABEN, SODIUM HYDROXIDE, SODIUM BENZOATE, CITRIC ACID, PROPYLPARABEN

Package Labeling:

INGREDIENTS AND APPEARANCE

ESSENTIAL BY ARTISTRY ANTI ACNE TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ZINC PIDOLATE (UNII: C32PQ86DH4)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CUCUMBER (UNII: YY7C30VXJT)
LEMON (UNII: 24RS0A988O)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LAURETH-7 (UNII: Z95S6G8201)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SALIX ALBA BARK (UNII: 205MXS71H7)
SORBITOL (UNII: 506T60A25R)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ACEROLA (UNII: XDD2WEC9L5)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHAMOMILE (UNII: FGL3685T2X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GINGER (UNII: C5529G5JPQ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-007-01	30 mL in 1 BOTTLE; 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)