Itk Body Blemish Treatment Mist
FDA Label NDC 71899-070

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Maesa, Llc. for the product Itk Body Blemish Treatment Mist (NDC 71899-070). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts:

Dist. by Maesa LLC, New York, NY 10281

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.

Otc - When Using

  • 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

  • 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

  • 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.

Principal Display Panel - 100 Ml Bottle Carton

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)

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