ITK BODY BLEMISH TREATMENT MIST- salicylic acid spray

ITK Body Blemish Treatment Mist by

Drug Labeling and Warnings

ITK Body Blemish Treatment Mist by is a Otc medication manufactured, distributed, or labeled by MAESA, LLC., Cosmetica Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

• For the treatment of acne.

Warnings

• For external use only.
• Flammable: Do not use near heat, flame, or while smoking.

• When using this product and other topical acne medications at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one medication should be used unless directed by a doctor.

• Stop use and ask a doctor if rash occurs.
• Avoid contact with eyes. If contact occurs, flush thoroughly with water.

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean skin thoroughly before applying.
• Use morning or night. Close eyes and mist onto clean, dry skin.
• Wait 20 – 30 seconds to dry before dressing or applying other products.

Inactive Ingredients

Water (Aqua/Eau), Alcohol Denat., Butylene Glycol, PPG-26- Buteth-26, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Glycerin, Mentha Piperita (Peppermint) Oil, Sodium Hydroxide, Glycyrrhiza Glabra (Licorice) Root Extract, Menthol, tert-Butyl Alcohol, Denatonium Benzoate, Limonene, Linalool.

Questions, Comments

YOU MAY REPORT AN ADVERSE REACTION TO: ITK C/O REPORT REACTION LLC, PO BOX 22, PLAINSBORO, NJ 08536-0222.

SPL UNCLASSIFIED SECTION

Dist. by Maesa LLC, New York, NY 10281

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

itk

SCAN ME

BLEMISH
TREATMENT MIST

treats acne
+ controls daily oil

3.3 FL. OZ. / 100 mL

INGREDIENTS AND APPEARANCE

ITK BODY BLEMISH TREATMENT MIST 
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71899-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71899-070-01	1 in 1 CARTON	08/01/2022
1		100 mL in 1 BOTTLE, PUMP; 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	08/01/2022

Labeler - MAESA, LLC. (144282311)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetica Labs		255080491	MANUFACTURE(71899-070)