Be Clarified Acne Gel-Cream Cleanser Salicylic Acid Acne Treatment

Cleanser by

Drug Labeling and Warnings

Cleanser by is a Otc medication manufactured, distributed, or labeled by Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CLEANSER- salicylic acid liquid 
Oxygen Development LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Be Clarified Acne Gel-Cream Cleanser Salicylic Acid Acne Treatment

Active Ingredient

Salicylic Acid 2.00%

Purpose

Acne Treatment

Uses

- For the treatment of acne

- Helps prevent new acne blemishes from forming

Warnings

For external use only

When using this product

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

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

Directions

- 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

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

CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)	0.56 mg  in 100 mg
WATER (UNII: 059QF0KO0R)	79.35 mg  in 100 mg
COCONUT ACID (UNII: 40U37V505D)	0.52 mg  in 100 mg
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)	0.768 mg  in 100 mg
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)	3.34 mg  in 100 mg
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	1.24 mg  in 100 mg
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)	4.2 mg  in 100 mg
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)	1.84 mg  in 100 mg
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)	0.725 mg  in 100 mg
PROPANEDIOL (UNII: 5965N8W85T)	2.99 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-068-01	1 in 1 CARTON	08/25/2022	02/23/2023
1		1 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	08/25/2022	02/23/2023

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-068)

Revised: 2/2023

Document Id: f55fd17f-c400-3da1-e053-2995a90ade8c

34390-5

Set id: e5e5624d-3a67-0f30-e053-2a95a90a7609

Version: 2

Effective Time: 20230223