ACNE SPOT TREATMENT- benzoyl peroxide cream 
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 Spot Treatment

Active Ingredient

Benzoyl Peroxide 5.00%

Purpose

Acne Treatment

Uses

For external use only

Do not use if

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

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 irritation occurs, only use one topical acne treatment at a time.
  • avoid unnecessary sun exposure and use sunscreen
  • avoid contact with eyes, lips, and mouth.
  • avoid contact with hair and dyed fabrics, which may be bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and consult

Stop use and consult with a doctor if

  • irritation becomes severe.

Keep out of reach of children

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Directions

Directions

Sensitivity Test for a new User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Water, Isostearyl Alcohol, Glycerin, Pentylene Glycol, Silica, Hamamelis Virginiana (Witch Hazel) Water, Epilobium Angustifolium Flower/Leaf/Stem Extract, Phragmites Communis Extract, Poria Cocos Extract, Niacinamide, Tocopheryl Acetate, Carbomer, Potassium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA.

Questions or Comments

Questions or comments?

Toll-free number 1-800-878-1978

PRIMARY PACKAGE

Tube

OUTER PACKAGE

Outer package

ACNE SPOT TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78518-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
FU LING (UNII: XH37TWY5O4)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78518-013-011 in 1 CARTON04/04/2023
115 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
Dermacare MFG116817470manufacture(78518-013)

Revised: 4/2023
Document Id: f8700864-81e8-62eb-e053-6394a90a4aeb
Set id: f8700864-81e9-62eb-e053-6394a90a4aeb
Version: 1
Effective Time: 20230403
 
MONAT GLOBAL CORP