Age Intervention Duality Md Cream
FDA Label NDC 65113-2373

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by G.s. Cosmeceutical Usa, Inc. for the product Age Intervention Duality Md (NDC 65113-2373). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, when using this product, do not use if you, stop use and ask a physician if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.
    • 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

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop Use And Ask A Physician If

  • irritation becomes severe

Otc - Keep Out Of Reach Of Children

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

MD

AGE INTERVENTION

DUALITY MD™

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

JANMARINI

Principal Display Panel (28 g Carton)

Principal Display Panel (28 g Carton)

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