CORAL ACTIVES 2 STEP ACNE TREATMENT SYSTEM- benzoyl peroxide gel 
Prime Enterprises Inc.

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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Coral Actives 2 Step Acne Treatment System

Active Ingredients

Benzoyl Peroxide 6%

Acne Medication

Use

for the treatment of acne

  • For external use only.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop use and ask a doctor if

  • Irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean skin thoroughly before applying this product
  • Cover the entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

Acrylates/C10-C30 Alkyl Acrylate Crosspolymer, Caprylic/Capris Triglyceride, Capryl Glycol, Carbomer, Dimethicone, Dimethyl Isorbide, Disodium EDTA, Ethylhexylglycern, Ethylparaben, Glycerin, Methylparaben, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Propylparaben, SeaWhip Extract, Sodium Hydroxide, Water

Questions? 888-968-0545

Coral Actives 2 Step Acne Treatment

Principle Display Panel

CORAL ACTIVES  2 STEP ACNE TREATMENT SYSTEM
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0187
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE61.62 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRICAPRIN (UNII: O1PB8EU98M)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0187-330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/12/201312/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/12/201312/31/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0187) , manufacture(58443-0187) , label(58443-0187)

Revised: 3/2022
Document Id: db11bc0f-3182-90aa-e053-2995a90ada8c
Set id: 20d42d7e-7123-299b-e054-00144ff88e88
Version: 4
Effective Time: 20220325
 
Prime Enterprises Inc.