LIQUID- 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

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 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

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

Directions

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

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

61354-091-01_AW61354-091-01_AW

LIQUID 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-091
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) 4.2 mg  in 100 mg
PROPANEDIOL (UNII: 5965N8W85T) 2.99 mg  in 100 mg
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) 2 mg  in 100 mg
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1) 0.56 mg  in 100 mg
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.79 mg  in 100 mg
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) 1.68 mg  in 100 mg
WATER (UNII: 059QF0KO0R) 78.25 mg  in 100 mg
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) 1.087 mg  in 100 mg
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 0.5 mg  in 100 mg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-091-021 in 1 CARTON03/22/2023
1NDC:61354-091-011 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00603/22/2023
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-091)

Revised: 3/2023
Document Id: f77f6887-f715-9d0a-e053-6394a90ab050
Set id: f77f6887-f714-9d0a-e053-6394a90ab050
Version: 1
Effective Time: 20230322
 
Oxygen Development LLC