FDA.reportPublic FDA data

ITK Body Blemish Treatment Mist

Manufacturer
MAESA, LLC. | Cosmetica Labs
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:42

Label at a glance#

ProductITK Body Blemish Treatment Mist
Active ingredientSalicylic Acid
Label structure10 sections

Indications and uses

For the treatment of acne.

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

  • 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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

itk

SCAN ME

BLEMISH
TREATMENT MIST

treats acne
+ controls daily oil

3.3 FL. OZ. / 100 mL

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71899-070-01ITK Body Blemish Treatment Mist100 mL in 1 BOTTLE, PUMPSPRAY1001
71899-070-01ITK Body Blemish Treatment Mist1 in 1 CARTONSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71899-070ITK BODY BLEMISH TREATMENT MIST (SALICYLIC ACID) SPRAY [MAESA, LLC.]12 package rows20240123_b67b910b-2475-4c39-85a9-7a46ed39eeab.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71899-07071899-070-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
DENATONIUM BENZOATE4YK5Z54AT2IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PPG-26-BUTETH-262II1K6TZ4PIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d2779c27-68b0-43e7-a7a3-e3208af27784b67b910b-2475-4c39-85a9-7a46ed39eeab2024-01-19WarningsExact identifier
spl id: d2779c27-68b0-43e7-a7a3-e3208af27784
spl set id: b67b910b-2475-4c39-85a9-7a46ed39eeab

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.