Soft Services Clearing Mist Breakout Tonic
FDA Label NDC 82030-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A To Z International Corporation for the product Soft Services Clearing Mist Breakout Tonic (NDC 82030-010). 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 active ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Salicylic Acid 1%

Purpose

Acne Treatment

Uses

• for the treatment of acne

Warnings

For external use only
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 medication should
be used unless directed by a doctor.

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 the skin thoroughly before applying this product • cover the entire
affected area 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 • if bothersome dryness or peeling occurs, reduce
application to once a day or every other day.

Inactive Ingredients

Water, Alcohol Deant., Aloe Barbadensis Leaf Juice, Niacinamide, Zinc PCA, Melaleuca Alternifolia Leaf Oil, Glycerin, Arctium Lappa Root Extract, Calendula Officinalis Flower Extract, Smilax Aristolochiaefolia Root Extrac, Citric Acid

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