FDA.reportPublic FDA data

PHARMA CLEAR CLEANSER

Manufacturer
PHARMAGEL INTERNATIONAL INC
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:17:13

Label at a glance#

ProductPHARMA CLEAR CLEANSER
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

Use for treatment of acne and to decrease bacteria on the skin.

Dosage and administration

Wet area. Dispense product into hands and massage gently onto face and body, avoiding the eye area. Rinse thoroughly with warm water and pat dry. For best results, use twice daily.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

PURPOSE

OTC - PURPOSE SECTION

Acne Medication

USES:

INDICATIONS & USAGE SECTION

Use for treatment of acne and to decrease bacteria on the skin.

WARNINGS

WARNINGS SECTION

For external use only

When using this product:

OTC - WHEN USING SECTION

• avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.

• 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.

• Limit use to the face and neck.

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 immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Wet area. Dispense product into hands and massage gently onto face and body, avoiding the eye area. Rinse thoroughly with warm water and pat dry. For best results, use twice daily.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, ACRYLATES COPOLYMER, COCAMIDOPROPYL BETAINE, GLYCERIN, CITRIC ACID, DISODIUM EDTA-COPPER, SODIUM HYDROXIDE, TRICLOSAN, PANTHENOL, BISABOLOL, GARCINIA MANGOSTANA (MANGOSTEEN) FRUIT EXTRACT, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHK_1A_RL-2_2PHK_1A_RL-2_2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN7
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD7
562600salicylic acid 2 % Facial Cleanser TonerSY7
562600salicylic acid 2 % Facial ScrubSY7
562600salicylic acid 2 % Medicated Liquid SoapSY7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67879-101-11PHARMA CLEAR CLEANSER175 mL in 1 TUBEGEL1757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67879-101PHARMA CLEAR CLEANSER (SALICYLIC ACID) GEL [PHARMAGEL INTERNATIONAL INC]7Current NDC, Legacy NDC, 1 package rows20240815_d2c39d80-5ccd-43a8-a8bf-eba502bfdbf1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
CARBOMER COPOLYMER TYPE AINACTIVE INGREDIENT71DD5V995L1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
DISODIUM EDTA-COPPERINACTIVE INGREDIENT6V475AX06U1
GARCINIA MANGOSTANA FRUITINACTIVE INGREDIENT832X5KK78Y1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5U1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
TRICLOSANINACTIVE INGREDIENT4NM5039Y5X1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67879-10167879-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM HYDROXIDE55X04QC32IIACT
TRICLOSAN4NM5039Y5XIACT
PANTHENOLWV9CM0O67ZIACT
LEVOMENOL24WE03BX2TIACT
GARCINIA MANGOSTANA FRUIT832X5KK78YIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
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
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
ndc (package): 67879-101-11
ndc (product): 67879-101
ndc11 (package): 67879010111
spl id: 1f946b90-c483-0cdf-e063-6294a90a86ef
spl set id: d2c39d80-5ccd-43a8-a8bf-eba502bfdbf1

Reported adverse events (FAERS/openFDA)#

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