BE CLARIFIED Acne Gel-Cream Cleanser Salicylic Acid Acne treatment

Manufacturer
Oxygen Development LLC
Effective date
2023-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:32

Label at a glance#

ProductLiquid
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne Helps prevent new acne blemishes from forming

Dosage and administration

Shake well before use Start with damp skin Apply a small amount onto your fingertips and emulsify Gently cleanse the skin using circular motions Rinse with warm water and gently pat the skin dry Follow with your MONAT Skincare Routine

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

Helps prevent new acne blemishes from forming

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne treatment at a time.

Avoid contact with eyes. If products occurs, rinse eyes thoroughly with water

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a poison control center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use

Start with damp skin

Apply a small amount onto your fingertips and emulsify

Gently cleanse the skin using circular motions

Rinse with warm water and gently pat the skin dry

Follow with your MONAT Skincare Routine

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Propanediol, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Niacinamide, Cocamide MIPA, Glycerin, PEG-150 Distearate, Stearic Acid, Coconut Acid, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, PEG-120 Methyl Glucose Dioleate, Caprylyl/Capryl Glucoside, Polyglyceryl-10 Laurate, Polyglyceryl-10 Oleate, Sodium Chloride, SOdium Benzoate, Potassium Sorbate

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

61354-091-01_AW61354-091-01_AW61354-091-01_AW61354-091-01_AW

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61354-091-022025-01-30C16284748780-12cef2736-97d7-d83d-e063-dadaa90ab31fBE CLARIFIED Acne Gel-Cream Cleanser Salicylic Acid Acne treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61354-091-01Liquid1 mg in 1 TUBELIQUID11
61354-091-02Liquid1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61354-091LIQUID (SALICYLIC ACID) LIQUID [OXYGEN DEVELOPMENT LLC]12 package rows20230323_f77f6887-f714-9d0a-e053-6394a90ab050.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-09161354-091-01, 61354-091-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
f77f6887-f715-9d0a-e053-6394a90ab050f77f6887-f714-9d0a-e053-6394a90ab0502023-03-22WarningsExact identifier
spl id: f77f6887-f715-9d0a-e053-6394a90ab050
spl set id: f77f6887-f714-9d0a-e053-6394a90ab050

Reported adverse events (FAERS/openFDA)#

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