FDA.reportPublic FDA data

Medicated Wash

Manufacturer
Vivier Pharma, Inc. | Dermolab Pharma Ltd
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:05

Label at a glance#

ProductMedicated Wash
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and white heads.

Dosage and administration

​Wet face using lukewarm water. Gently massage over the face using fingertips. Rinse completely. Use both morning and night or as directed by a physician. If dryness or peeling occurs, reduce application to once a day or every other day. Other Information Store at room temperature (15-30°C / 59-86°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid USP 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and white heads.

WARNINGS For exrernal use only

WARNINGS SECTION

Ask a doctor before use if you are

  • 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

When using this product

  • Do not get into eyes.

Stop use and ask a doctor if

  • Excessive skin irritation develops or increases.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • ​Wet face using lukewarm water.
  • Gently massage over the face using fingertips.
  • Rinse completely.
  • Use both morning and night or as directed by a physician.
  • If dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

  • Store at room temperature

    (15-30°C / 59-86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Alcohol, Citric Acid, Disodium
Cocoamphodiacetate, Disodium Cocoyl Glutamate,
DMDM Hydantoin, Ethoxydiglycol, Fragrance,
Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate,
PEG-120 Methyl Glucose Dioleate, Sodium
Hydroxide, Sodium Lauroyl Sarcosinate, Water / Eau.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1Label 2Label 2Label 3Label 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN3
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD3
562600salicylic acid 2 % Facial Cleanser TonerSY3
562600salicylic acid 2 % Facial ScrubSY3
562600salicylic acid 2 % Medicated Liquid SoapSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67226-1021-1Medicated Wash150 mL in 1 BOTTLE, PUMPLIQUID1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-1021MEDICATED WASH (SALICYLIC ACID) LIQUID [VIVIER PHARMA, INC.]3Current NDC, Legacy NDC, 1 package rows20231115_e90ab8b6-6a77-4e02-9d71-45cd7383cb0a.zip

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
67226-102167226-1021-1

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
ALCOHOL3K9958V90MIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
DISODIUM COCOYL GLUTAMATEMBK0CP8F5AIACT
DMDM HYDANTOINBYR0546TOWIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
HEXAMIDINE DIISETHIONATE023XA5Z50LIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
ndc (package): 67226-1021-1
ndc (product): 67226-1021
ndc11 (package): 67226102101
spl id: 0a1fa998-dcdd-c181-e063-6294a90ad098
spl set id: e90ab8b6-6a77-4e02-9d71-45cd7383cb0a
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
ndc (package): 67226-1021-1
ndc11 (package): 67226102101

Reported adverse events (FAERS/openFDA)#

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