FDA.reportPublic FDA data

Soft Services CLEARING Mist Breakout Tonic

Manufacturer
A TO Z INTERNATIONAL CORPORATION
Effective date
2021-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:10

Label at a glance#

ProductSoft Services CLEARING Mist Breakout Tonic
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

• for the treatment of acne

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

• for the treatment of acne

Warnings

WARNINGS SECTION

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

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 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Email us at info@softservices.co or call us toll-free 1-844-959-0666

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82030-010-04.jpg82030-010-04.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2560235salicylic acid 1 % Topical SprayPSN1
2560235salicylic acid 10 MG/ML Topical SpraySCD1
2560235salicylic acid 1 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82030-010-042025-01-30C16284748780-12cef2736-82c4-d83d-e063-dadaa90ab31fDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82030-010-04Soft Services CLEARING Mist Breakout Tonic1 in 1 CARTONLIQUID11
82030-010-04Soft Services CLEARING Mist Breakout Tonic4 g in 1 TUBELIQUID41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82030-010SOFT SERVICES CLEARING MIST BREAKOUT TONIC (ACNE TREATMENT) LIQUID [A TO Z INTERNATIONAL CORPORATION]1Legacy NDC, 2 package rows20210701_a0c1e6b5-b0cb-4dea-abca-d1efbcacc40d.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82030-01082030-010-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
NIACINAMIDE25X51I8RD4IACT
ZINCJ41CSQ7QDSIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
GLYCERINPDC6A3C0OXIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
SMILAX ARISTOLOCHIIFOLIA ROOTNR100Y25G0IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
c5fc1ecd-ea39-8b7a-e053-2a95a90aad0da0c1e6b5-b0cb-4dea-abca-d1efbcacc40d2021-06-30WarningsExact identifier
spl id: c5fc1ecd-ea39-8b7a-e053-2a95a90aad0d
spl set id: a0c1e6b5-b0cb-4dea-abca-d1efbcacc40d

Reported adverse events (FAERS/openFDA)#

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