AGE INTERVENTION DUALITY- benzoyl peroxide cream

AGE INTERVENTION DUALITY by

Drug Labeling and Warnings

AGE INTERVENTION DUALITY by is a Otc medication manufactured, distributed, or labeled by G.S. COSMECEUTICAL USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

AGE INTERVENTION DUALITY 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65113-2372
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 OLIGOPEPTIDE (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
Color	YELLOW (VERY PALE YELLOW)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65113-2372-2	28 g in 1 BOTTLE, PUMP

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	Business Operations
G.S. COSMECEUTICAL USA, INC.		017014734	MANUFACTURE