FDA.reportPublic FDA data

Be Clarified Acne Gel-Cream Cleanser Salicylic Acid Acne Treatment

Manufacturer
Oxygen Development LLC
Effective date
2022-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:55:04

Label at a glance#

ProductCleanser
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 weel 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 2.00%

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 the one topical acne treatment at a time. Avoid contact with eyes. IF contact occurs rinse eyes thoroughly with water.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If podruct is swallowed, get medical help or contact a poison control center inmediately

Directions

DOSAGE & ADMINISTRATION SECTION

- Shake weel 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 Isethionate, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, 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

61354-068-01_aw61354-068-01_aw61354-068-01_aw61354-068-01_aw

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61354-06861354-068-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
WATER059QF0KO0RIACT
COCONUT ACID40U37V505DIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
PROPANEDIOL5965N8W85TIACT

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
f55fd17f-c400-3da1-e053-2995a90ade8ce5e5624d-3a67-0f30-e053-2a95a90a76092023-02-23WarningsExact identifier
spl set id: e5e5624d-3a67-0f30-e053-2a95a90a7609

Reported adverse events (FAERS/openFDA)#

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