FDA.reportPublic FDA data

Phisoderm Anti-Blemish Gel Cleanser

Manufacturer
The Mentholatum Company
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:16

Label at a glance#

ProductPhisoderm Anti-Blemish Gel Cleanser
Active ingredientSALICYLIC ACID
Label structure10 sections

Indications and uses

treats and helps prevent acne blemishes

Dosage and administration

wet face, then gently massage onto skin Rinse well and pat dry use twice daily

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

treats and helps prevent acne blemishes

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes. If contact occurs, flush thoroughly with water.
  • 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.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet face, then gently massage onto skin
  • Rinse well and pat dry
  • use twice daily

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, lauramidopropyl betaine, sodium C14-16 olefin sulfonate, lauryl glucoside, trolamine, butylene glycol, chamomilla recutita (matricaria) flower extract, disodium EDTA, DMDM hydantoin, fragrance, glycerin, hydroxyphenyl propamidobenzoic acid, iodopropynyl butylcarbamate, lactic acid, pentylene glycol, polysorbate 20, sodium chloride

Questions?

OTC - QUESTIONS SECTION

Toll free 1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phisoderm Anti-Blemish Gel Cleanser
Phisoderm Anti-Blemish Gel Cleanser

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Phisoderm Anti-Blemish Gel Cleanser
Phisoderm Anti-Blemish Gel Cleanser

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1423494PHISODERM 2 % Medicated Liquid SoapPSN4
562600salicylic acid 2 % Medicated Liquid SoapPSN4
1423494salicylic acid 20 MG/ML Medicated Liquid Soap [Phisoderm Clear Confidence Daily Gel Face Wash]SBD4
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD4
1423494Phisoderm Clear Confidence Daily Gel Face Wash 2 % Medicated Liquid SoapSY4
1423494Phisoderm Clear Confidence Daily Gel Face Wash 20 MG/ML Medicated Liquid SoapSY4
562600salicylic acid 2 % Facial Cleanser TonerSY4
562600salicylic acid 2 % Facial ScrubSY4
562600salicylic acid 2 % Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10742-8417-12023-02-07C16284748780-1f386c649-b499-0266-e053-dadaa90a7c1aDrug Facts - pHisoderm Anti-Blemish Gel Cleanser
10742-8417-12023-01-30C16284748780-1f386c649-b499-0266-e053-dadaa90a7c1aDrug Facts - pHisoderm Anti-Blemish Gel Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10742-8417-1Phisoderm Anti-Blemish Gel Cleanser177 g in 1 TUBEGEL1774

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10742-8417PHISODERM ANTI-BLEMISH GEL CLEANSER (SALICYLIC ACID) GEL [THE MENTHOLATUM COMPANY]4Current NDC, Legacy NDC, 1 package rows20241219_9fd851bf-1113-488b-ad16-1a3ce52a87d5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOW1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYDROXYPHENYL PROPAMIDOBENZOIC ACIDINACTIVE INGREDIENT25KRT26H771
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
LACTIC ACIDINACTIVE INGREDIENT33X04XA5AT1
LAURAMIDOPROPYL BETAINEINACTIVE INGREDIENT23D6XVI2331
LAURYL GLUCOSIDEINACTIVE INGREDIENT76LN7P7UCU1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5U1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10742-841710742-8417-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURAMIDOPROPYL BETAINE23D6XVI233IACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
TROLAMINE9O3K93S3TKIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CHAMOMILEFGL3685T2XIACT
EDETATE DISODIUM7FLD91C86KIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM CHLORIDE451W47IQ8XIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

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 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHGEL / TOPICAL5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DMDM HYDANTOINDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTIC ACIDLACTIC ACID33X04XA5ATGEL / TOPICAL30 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / TOPICAL0.18 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 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
Phisoderm Anti-Blemish Gel CleanserSALICYLIC ACIDThe Mentholatum Company9fd851bf-1113-488b-ad16-1a3ce52a87d52024-12-17WarningsExact identifier
ndc (package): 10742-8417-1
ndc (product): 10742-8417
ndc11 (package): 10742841701
spl id: 2979b08a-6fa5-17cc-e063-6294a90a88c3
spl set id: 9fd851bf-1113-488b-ad16-1a3ce52a87d5

Reported adverse events (FAERS/openFDA)#

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