MedPath

Neutrogena Oil Free Acne Stress Control Triple Action Toner

Neutrogena Oil - Free Acne Stress Control Triple - Action Toner

Approved
Approval ID

36412939-97bc-6cb1-e063-6294a90aef48

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 29, 2025

Manufacturers
FDA

Kenvue Brands LLC

DUNS: 118772437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic Acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69968-0925
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 29, 2025
FDA Product Classification

INGREDIENTS (18)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
PPG-5-CETETH-20Inactive
Code: 4AAN25P8P4
Classification: IACT
GREEN 5Inactive
Code: 8J6RDU8L9X
Classification: IACT
C12-15 ALKYL LACTATEInactive
Code: GC844VRD7E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CETYL LACTATEInactive
Code: A7EVH2RK4O
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEInactive
Code: H2KVQ74JM4
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CUCUMIS SATIVUS (CUCUMBER) FRUITInactive
Code: YY7C30VXJT
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
YELLOW 5Inactive
Code: I753WB2F1M
Classification: IACT
BLUE 1Inactive
Code: H3R47K3TBD
Classification: IACT
SALICYLIC ACIDActive
Quantity: 20 mg in 1 mL
Code: O414PZ4LPZ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/29/2025

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

NEW LOOK

Neutrogena®

DERMATOLOGIST RECOMMENDED BRAND

Oil-Free

Acne Stress

Control®

Triple-Action Toner

2% salicylic acid acne treatment

MICROCLEAR®

Technology

1 Treats acneeven before it emerges

2 Reduces oil & shine

3 Refreshes & smooths

8 FL. OZ. (236 mL)

Neutrogena

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/29/2025

Use

For the treatment of acne.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/29/2025

Active ingredient

Salicylic Acid 2%

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/29/2025

Distributed by:

Kenvue Brands LLC

Summit, NJ 07901

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/29/2025

Purpose

Acne medication

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/29/2025

Other information

Store at Room Temperature.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/29/2025

Warnings

For external use only.

Flammable: Keep away from fire or flame.

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.
  • if eye contact occurs, flush thoroughly with water.

*Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/29/2025

Directions

  • cleanse skin thoroughly before applying this product
  • 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 doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/29/2025

Inactive ingredients

Water, Alcohol Denat., Butylene Glycol, PPG-5-Ceteth-20, C12-15 Alkyl Lactate, Fragrance, Sodium Citrate, Cocamidopropyl

PG-Dimonium Chloride Phosphate, Sodium Hydroxide, Benzalkonium Chloride, Cetyl Lactate, Disodium EDTA, Glycerin, Camellia Sinensis Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Blue 1, Green 5, Yellow 5

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/29/2025

Questions?

Call toll-free800-582-4048 or215-273-8755 (collect) or visit www.neutrogena.com

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Neutrogena Oil Free Acne Stress Control Triple Action Toner - FDA Drug Approval Details