ARTISTRY STUDIO DONE WITH ZIT ACNE TREATMENT CLEARING GEL- salicylic acid gel

Artistry Studio Done With Zit Acne Treatment Clearing Gel by

Drug Labeling and Warnings

Artistry Studio Done With Zit Acne Treatment Clearing Gel 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 2.0% (W/W)

Purpose

Acne Treatment

Use

• For the treatment of acne.

Warnings

For external use only

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Using other topical acne medications 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.

Apply to affected areas only. Do not use on broken skin or apply tolarge areas of the body

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. Cover the entire affected areas 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/health care practitioner.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

water/aqua/eau, alcohol denat., PEG-8, hydroxyethylcellulose, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, sodium hydroxide, disodium EDTA, allantoin, PEG-60 almond glycerides, fragrance/parfum, butylene glycol, pentylene glycol, caffeine, isononyl isononanoate, lecithin, maltodextrin, phenoxyethanol, salvia hispanica seed extract, mangifera indica (mango) fruit extract, syringa vulgaris (lilac) extract, sodium citrate, ceramide NP, citric acid, potassium sorbate, sodium benzoate, beta-sitosterol, chlorphenesin, orthosiphon stamineus extract, xanthan gum, tocopherol, limonene, citral, linalool

Package Labeling:

INGREDIENTS AND APPEARANCE

ARTISTRY STUDIO DONE WITH ZIT ACNE TREATMENT CLEARING GEL 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-045
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)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALLANTOIN (UNII: 344S277G0Z)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAFFEINE (UNII: 3G6A5W338E)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHIA SEED (UNII: NU0OLX06F8)
MANGO (UNII: I629I3NR86)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-045-00	1 in 1 CARTON	06/23/2021
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	06/23/2021

Labeler - Access Business Group LLC (839830713)

Establishment
Name	Address	ID/FEI	Business Operations
Access Business Group LLC		839830713	manufacture(10056-045)