FDA.reportPublic FDA data

Perricone Acne Relief Calming and Soothing Clay Mask

Manufacturer
Bentley Laboratories, LLC
Effective date
2021-10-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:13

Label at a glance#

ProductPerricone Acne Relief Calming and Soothing Clay Mask
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Salicylic Acid (2.0%)

OTC - PURPOSE SECTION

Purpose
Acne Treatment

INDICATIONS & USAGE SECTION

Use ■ For the treatment of acne.

WARNINGS SECTION

Warnings
For external use only.

Keep out of eyes. If product enters the eyes,
wash out thoroughly with warm water.

When Using This Product ■ skin irritation
and dryness is 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.

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 the skin thoroughly
before applying this product. ■ cover the
entire affected area with a thin layer morning
& evening. No rinsing is needed. Wait until
dry before applying treatment or moisturizer.
■ 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 Water/Aqua/Eau,
Glycerin, PEG-40 Hydrogenated Castor Oil,
Bentonite, Coco-Caprylate, Magnesium Aluminum
Silicate, Titanium Dioxide, Butylene Glycol,
Methyl Gluceth-20 Benzoate, Glyceryl Stearate,
Lactobacillus Ferment, Sodium Metabisulfite,
Tocopherol, Sodium Hydroxide, 1,2-Hexanediol,
Caprylyl Glycol, Polyacrylamide, Epilobium
Angustifolium Flower/Leaf/Stem Extract, C13-14
Isoparaffin, Succinic Acid, Xanthan Gum,
Lactic Acid, Allantoin, Laureth-7, Disodium
EDTA, Phenoxyethanol

OTC - QUESTIONS SECTION

Questions?1-888-823-7837

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Perricone MD

ACNE RELIEF

Calming &
Soothing
Clay Mask
Salicylic Acid Acne Treatment

Lactobacillus Ferment,
Willowherb, Bentonite Clay


℮ 59 mL / 2 US fl. oz.

Dist. By: NV Perricone LLC. Shepherdsville, KY
40165. Made in USA of foreign and domestic
components. Perricone MD, a THG brand THG
Beauty Limited Voyager House, M90 3DQ, UK
73 Rue Saint-Anne, 75002, Paris, FR. 651362
1 888 823 7837
perriconemd.com

59 nL Carton

156 ClayMask156 ClayMask

156 ClayMask Tube156 ClayMask Tube

10 mL Packet

156-51 ClayMask Packet156-51 ClayMask Packet

res

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54111-156-502023-01-30C16284748780-1f386c649-c90c-0266-e053-dadaa90a7c1aPerricone MD Acne Relief Calming and Soothing Clay Mask
54111-156-512023-01-30C16284748780-1f386c649-c90c-0266-e053-dadaa90a7c1aPerricone MD Acne Relief Calming and Soothing Clay Mask

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-156-50Perricone Acne Relief Calming and Soothing Clay Mask59 mL in 1 TUBELOTION592
54111-156-50Perricone Acne Relief Calming and Soothing Clay Mask1 in 1 CARTONLOTION12
54111-156-51Perricone Acne Relief Calming and Soothing Clay Mask10 mL in 1 PACKETLOTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-156PERRICONE ACNE RELIEF CALMING AND SOOTHING CLAY MASK (SALICYLIC ACID) LOTION [BENTLEY LABORATORIES, LLC]2Legacy NDC, 3 package rows20211201_5b2dfdc9-209e-4884-a7e6-c7916ab6c32e.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-15654111-156-50, 54111-156-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
BENTONITEA3N5ZCN45CIACT
COCO-CAPRYLATE4828G836N6IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
METHYL GLUCETH-20J3QD0LD11PIACT
BENZOIC ACID8SKN0B0MIMIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LACTOBACILLUS FERMENTUM2C1F12C6APIACT
SODIUM METABISULFITE4VON5FNS3CIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYDROXIDE55X04QC32IIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP08H094218DIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
SUCCINIC ACIDAB6MNQ6J6LIACT
XANTHAN GUMTTV12P4NEEIACT
LACTIC ACID33X04XA5ATIACT
ALLANTOIN344S277G0ZIACT
LAURETH-7Z95S6G8201IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
f99e3472-7e11-4394-a995-a92058db59fd5b2dfdc9-209e-4884-a7e6-c7916ab6c32e2021-10-04WarningsExact identifier
spl id: f99e3472-7e11-4394-a995-a92058db59fd
spl set id: 5b2dfdc9-209e-4884-a7e6-c7916ab6c32e

Reported adverse events (FAERS/openFDA)#

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