AGE INTERVENTION DUALITY MD- benzoyl peroxide cream 
G.S. COSMECEUTICAL USA, 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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AGE INTERVENTION
DUALITY MD™

Drug Facts

Active Ingredients

Benzoyl Peroxide-10%

Purpose

Anti-acne

Uses

For the treatment of Acne. Reduces the severity of acne blemishes, acne pimples, blackheads, whiteheads and allows the skin to heal.

Warnings

For External Use Only.

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • avoid contact with the eyes, lips and mouth
  • 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 ask a physician if

  • irritation becomes severe

Keep out of reach of children. If accidentally swallowed, seek medical help immediately or contact the Poison Control Center.

DIRECTIONS

Inactive Ingredients

Water (Aqua), Propylene Glycol, Glycerin, Sorbitol, Polyacrylamide, C13-14 Isoparaffin, Cyclopentasiloxane, Cyclohexasiloxane, Carbomer, Laureth 7, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylbaraben

PRINCIPAL DISPLAY PANEL - 28 g Carton

MD

AGE INTERVENTION

DUALITY MD

Benzoyl Peroxide 10%
Adult Acne Treatment Cream
and Anti-Aging Complex

JANMARINI

Principal Display Panel - 28 g Carton
AGE INTERVENTION DUALITY MD 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-2373
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
RETINOL (UNII: G2SH0XKK91)  
SORBITOL (UNII: 506T60A25R)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
CHRYSIN (UNII: 3CN01F5ZJ5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARETH-20 (UNII: L0Q8IK9E08)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Product Characteristics
ColorYELLOW (VERY PALE YELLOW) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65113-2373-228 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D05/01/2011
Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE(65113-2373)

Revised: 1/2022
Document Id: 89fed0ba-a212-4fbb-b4de-48d2a29ea37b
Set id: 6d885fe2-8a2d-44d4-84d9-932c48260f79
Version: 2
Effective Time: 20220111
 
G.S. COSMECEUTICAL USA, INC.