FDA.reportPublic FDA data

AGE INTERVENTION DUALITY

Manufacturer
G.S. COSMECEUTICAL USA, INC.
Effective date
2024-11-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:37:21

Label at a glance#

ProductAGE INTERVENTION DUALITY
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide-10%

Purpose

OTC - PURPOSE SECTION

Anti-acne

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For External Use Only.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • irritation becomes severe

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 28 g Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106315benzoyl peroxide 10 % Topical CreamPSN4
106315benzoyl peroxide 100 MG/ML Topical CreamSCD4
106315benzoyl peroxide 10 % Topical CreamSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65113-2372-22022-01-12C16284748780-1960f7f55-c75e-8e05-e053-dbdaa90a074aAGE INTERVENTION ® DUALITY ™
65113-2372-22019-10-29C16284748780-1960f7f55-c75e-8e05-e053-dbdaa90a074aAGE INTERVENTION ® DUALITY ™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65113-2372-2AGE INTERVENTION DUALITY28 g in 1 BOTTLE, PUMPCREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-2372AGE INTERVENTION DUALITY (BENZOYL PEROXIDE) CREAM [G.S. COSMECEUTICAL USA, INC.]4Current NDC, Legacy NDC, 1 package rows20241116_33fb5893-ea63-49a3-bb02-6b98c747c4fe.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C601
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CHRYSININACTIVE INGREDIENT3CN01F5ZJ51
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A0651
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86C1
PALMITOYL TETRAPEPTIDE-7INACTIVE INGREDIENTQ41S464P1R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
RETINOLINACTIVE INGREDIENTG2SH0XKK911
SORBITOLINACTIVE INGREDIENT506T60A25R1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E081
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65113-237265113-2372-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
STEARYL ALCOHOL2KR89I4H1YIACT
RETINOLG2SH0XKK91IACT
SORBITOL506T60A25RIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
CHRYSIN3CN01F5ZJ5IACT
DIMETHICONE92RU3N3Y1OIACT
STEARETH-20L0Q8IK9E08IACT
PHENOXYETHANOLHIE492ZZ3TIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RCREAM / TOPICAL36.8 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
STEARETH-20STEARETH-20L0Q8IK9E08CREAM / TOPICAL4.15 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE INTERVENTION DUALITYBENZOYL PEROXIDEG.S. COSMECEUTICAL USA, INC.33fb5893-ea63-49a3-bb02-6b98c747c4fe2024-11-15WarningsExact identifier
ndc (package): 65113-2372-2
ndc (product): 65113-2372
ndc11 (package): 65113237202
spl id: 698580fb-8dea-4a63-9cbb-3a1df814b407
spl set id: 33fb5893-ea63-49a3-bb02-6b98c747c4fe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.