FDA.reportPublic FDA data

Clarifying Bacne Spray

Manufacturer
Dermalogica, LLC. | Bell International
Effective date
2025-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:51:15

Label at a glance#

ProductClarifying Bacne
Active ingredientSalicylic Acid
Label structure10 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. Hold the spray about...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid (1.0%)

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • In or near eyes. If contact occurs, flush thoroughly with water.
  • If irritation develops, discontinue use.

When using this product

OTC - WHEN USING SECTION

  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • Do not inhale.

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.

Contents under pressure

SPL UNCLASSIFIED SECTION

  • Do not puncture or incinerate can.
  • Do not store at temperatures above 120°F.

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.
  • Hold the spray about a foot and a half away from your body and mist onto clean, dry skin.
  • Let it sink into skin for 30-60 seconds.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Hamamelis Virginiana (Witch Hazel) Water, Isoceteth-20, Ethoxydiglycol, Hexylene Glycol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Cymbopogon Schoenanthus Oil, Argania Spinosa Kernel Oil, Citrus Reticulata (Tangerine) Leaf Oil, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Porphyra Umbilicalis Extract, Serenoa Serrulata Fruit Extract, Sesamum Indicum (Sesame) Seed Oil, Butylene Glycol, Tocopherol, Beta-Sitosterol, Ethylhexylglycerin, Polysorbate 20, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Benzoic Acid, Limonene, Linalool, Citral, Geraniol, Citronellol, Coumarin.

Questions or comments

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clarifying
bacne spray

clears + rebalances

dermalogica
clear start

6 US FL OZ / 177 mL ℮

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2560235salicylic acid 1 % Topical SprayPSN2
2560235salicylic acid 10 MG/ML Topical SpraySCD2
2560235salicylic acid 1 % Topical SpraySY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-782-02Clarifying Bacne177 mL in 1 BOTTLE, SPRAYSPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-782CLARIFYING BACNE (SALICYLIC ACID) SPRAY [DERMALOGICA, LLC.]2Current NDC, 1 package rows20250109_eb13bf93-2554-4666-bd74-637b2eed7b50.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-78268479-782-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
HAMAMELIS VIRGINIANA TOP WATERNT00Y05A2VIACT
Isoceteth-20O020065R7ZIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
Hexylene GlycolKEH0A3F75JIACT
PhenoxyethanolHIE492ZZ3TIACT
Polysorbate 207T1F30V5YHIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
Sodium Hydroxide55X04QC32IIACT
TEA TREE OILVIF565UC2GIACT
Ethylhexylglycerin147D247K3PIACT
LAVENDER OILZBP1YXW0H8IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
Butylene Glycol3XUS85K0RAIACT
LEMON OIL, DISTILLEDET5GD00TRPIACT
Cymbopogon Schoenanthus OilXE7K568ILOIACT
ARGAN OIL4V59G5UW9XIACT
Benzoic Acid8SKN0B0MIMIACT
CITRUS AURANTIUM FRUIT OIL59JDQ5VT0TIACT
SESAME OILQX10HYY4QVIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
TocopherolR0ZB2556P8IACT
.BETA.-SITOSTEROLS347WMO6M4IACT
SAW PALMETTOJ7WWH9M8QSIACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CITRALT7EU0O9VPPIACT
GeraniolL837108USYIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
CoumarinA4VZ22K1WTIACT

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
Clarifying BacneSALICYLIC ACIDDermalogica, LLC.eb13bf93-2554-4666-bd74-637b2eed7b502025-01-02WarningsExact identifier
ndc (package): 68479-782-02
ndc (product): 68479-782
ndc11 (package): 68479078202
spl id: 15dfd4cc-c032-41df-be78-ea9110e47edb
spl set id: eb13bf93-2554-4666-bd74-637b2eed7b50

Reported adverse events (FAERS/openFDA)#

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