FDA.reportPublic FDA data

Clarity Clear Skin Essentials

Manufacturer
Melaleuca, Inc.
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:41:43

Label at a glance#

ProductClarity Clear Skin Essentials Deep-Cleaning Astringent
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

INDICATIONS & USAGE SECTION

Use for the treatment and management of acne

Warnings

WARNINGS SECTION

For external use only. Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - WHEN USING SECTION

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medicationat the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if excessive irritation of the skin develops

STORAGE AND HANDLING SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions • clean skin thoroughly before applying this product • moisten a cotton ball, 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 INGREDIENT SECTION

Inactive ingredients allantoin, aloe barbadensis leaf juice powder, butylene glycol, camellia oleifera (green tea) leaf extract, chamomillia recuttia (matricaria) flower extract, fragrance, hamamelia virginiana (witch hazel) extract, melaleuca alternifolia (tea tree) leaf oil, menthol panthenol, pentylene glycol, polyquaternium-7 propandiol, PPG-5-ceteth-20, SD alcohol 40-B, sodium citrate, water, zinc PCA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-221-042025-03-17C16284748780-19d75b9d0-95bf-f424-e053-dadaa90a57ceClarity Clear Skin Essentials Deep-Cleaning Astringent
54473-221-042025-01-30C16284748780-19d75b9d0-95bf-f424-e053-dadaa90a57ceClarity Clear Skin Essentials Deep-Cleaning Astringent
54473-221-042020-03-19C16284748780-19d75b9d0-95bf-f424-e053-dadaa90a57ceClarity Clear Skin Essentials Deep-Cleaning Astringent
54473-221-042020-01-31C16284748780-19d75b9d0-95bf-f424-e053-dadaa90a57ceClarity Clear Skin Essentials Deep-Cleaning Astringent

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA3
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C603
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X3
HAMAMELIS VIRGINIANA TOPINACTIVE INGREDIENTUDA30A2JJY3
MENTHOLINACTIVE INGREDIENTL7T10EIP3A3
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z3
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG3
PPG-5-CETETH-20INACTIVE INGREDIENT4AAN25P8P43
PROPANEDIOLINACTIVE INGREDIENT5965N8W85T3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR3
WATERINACTIVE INGREDIENT059QF0KO0R3
ZINC PIDOLATEINACTIVE INGREDIENTC32PQ86DH43

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
54473-22154473-221-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
CHAMOMILEFGL3685T2XIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
MENTHOLL7T10EIP3AIACT
PANTHENOLWV9CM0O67ZIACT
PENTYLENE GLYCOL50C1307PZGIACT
PPG-5-CETETH-204AAN25P8P4IACT
PROPANEDIOL5965N8W85TIACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
ZINC PIDOLATEC32PQ86DH4IACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 equally ranked IID candidates

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
308e45d7-11dc-d44f-e063-6394a90ae4c3a665ab62-e1b5-4e7a-b015-f447e54125842025-03-17WarningsExact identifier
spl set id: a665ab62-e1b5-4e7a-b015-f447e5412584

Reported adverse events (FAERS/openFDA)#

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