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Name:Age Intervention Duality
Manufacturer:G.s. Cosmeceutical Usa, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


AGE INTERVENTION® DUALITY™

AGE INTERVENTION DUALITY - 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

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

  • Clean the skin thoroughly before applying this product.
  • This product contains two parts. Dispense equal quantities of product from each of the two pumps, then briefly mix the two parts together on your palm.
  • 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 physician.
  • 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 physician.

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

AGE INTERVENTION®
DUALITY

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

JANMARINI
SKIN RESEARCH®

28 g / 1 oz.

PRINCIPAL DISPLAY PANEL - 28 g Carton

AGE INTERVENTION DUALITY 
benzoyl peroxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65113-2372
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
GLYCERYL STEARATE CITRATE  
POLYSORBATE 20  
POLYSORBATE 60  
STEARYL ALCOHOL  
RETINOL  
SORBITOL  
CAMELLIA OLEIFERA LEAF  
PALMITOYL TETRAPEPTIDE-7  
PALMITOYL OLIGOPEPTIDE  
CHRYSIN  
DIMETHICONE  
STEARETH-20  
PHENOXYETHANOL  
HEXYLENE GLYCOL  
ETHYLHEXYLGLYCERIN  
CAPRYLYL GLYCOL  
Product Characteristics
Color YELLOW (VERY PALE YELLOW) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65113-2372-2 28 g in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333D 05/01/2011

Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
Establishment
Name Address ID/FEI Operations
G.S. COSMECEUTICAL USA, INC. 017014734 MANUFACTURE

Revised: 05/2011 G.S. COSMECEUTICAL USA, INC.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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