ACNE CLEANSER- salycilic acid gel 
MONAT GLOBAL CORP

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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MONAT Be Clarified Acne Gel-Cream Cleanser

Active Ingredient

Salicylic Acid 2.00%

Purpose

Acne Treatment

Uses

For external use only

When using this product

  • skin irritation and dryness are more likely to occur if you use another topicalk acne medication at the same time. If irriatation occurs, only use 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 product is swallowed, get medical help or contact a poison control center right immediately.

Directions

Directions

Inactive Ingredients

Water, Sodium Cocoyl Glutamate, Propanediol, Sorbeth-230 Tetraoleate, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Cocoyl Isethionate, PEG-120 Methyl Glucose Dioleate, Niacinamide, Cocamide MIPA, Glycerin, Coconut Acid, Sodium Isethionate, Sodium PCA, Maclura Cochinchinensis Leaf Prenylflavonoids, Glycol Distearate, Laureth-4, Sodium Chloride, Sodium Benzoate, Potassium Sorbate, Polyquaternium-10, Decyl Glucoside, Sorbitan Laurate, Isopropyl Alcohol.

Questions or Comments

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

Primary Package

OUTER PACKAGE

Outer packageSECONDARY-OUTER PACKAGE

ACNE CLEANSER 
salycilic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78518-011
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
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
DECYL GLUCOSIDE, .ALPHA.- (UNII: 47YY6O286H)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
COCONUT ACID (UNII: 40U37V505D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MACLURA COCHINCHINENSIS WHOLE (UNII: X083FY34PH)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78518-011-011 in 1 CARTON04/04/2023
1120 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00604/04/2023
Labeler - MONAT GLOBAL CORP (027036949)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development137098492manufacture(78518-011)

Revised: 3/2023
Document Id: f54d0bad-65ce-4281-e053-2a95a90a9e52
Set id: f54d0bad-65cd-4281-e053-2a95a90a9e52
Version: 1
Effective Time: 20230331
 
MONAT GLOBAL CORP