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Dickinsons Original Witch Hazel Clarifying Foam Cleanser

Dickinson's Original Witch Hazel Clarifying Foam Cleanser

Approved
Approval ID

63f30249-2a1f-403c-9bb3-8c0c4c9dde43

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 10, 2025

Manufacturers
FDA

Dickinson Brands Inc.

DUNS: 124620340

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 Code52651-048
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 10, 2025
FDA Product Classification

INGREDIENTS (15)

SALICYLIC ACIDActive
Quantity: 0.032 g in 1.58 mL
Code: O414PZ4LPZ
Classification: ACTIB
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
HAMAMELIS VIRGINIANA TOP WATERInactive
Code: NT00Y05A2V
Classification: IACT
HYDROGENATED SOYBEAN LECITHINInactive
Code: H1109Z9J4N
Classification: IACT
MELALEUCA ALTERNIFOLIA FLOWERING TOPInactive
Code: 5AZ4S6N66F
Classification: IACT
SUCROSE STEARATEInactive
Code: 274KW0O50M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EUCALYPTOLInactive
Code: RV6J6604TK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
CERAMIDE NPInactive
Code: 4370DF050B
Classification: IACT
COCAMIDOPROPYL DIMETHYLAMINEInactive
Code: L36BM7DG2T
Classification: IACT
COCO-GLUCOSIDEInactive
Code: ICS790225B
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/10/2025

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

NEW!

ALCOHOL & FRAGRANCE FREE
DICKINSON'S®
ORIGINAL WITCH HAZEL

ACNE
CLEAR SKIN
CLARIFYING
FOAM
CLEANSER

2% Salicylic Acid Acne Treatment
+ Niacinamide

clears & helps prevent breakouts
defends against irritation

helps strengthen skin barrier
ultra-lightweight for face & body

dermatologist tested

powered by
100% NATURAL DISTILLED
WITCH HAZEL

7 FL OZ
207 mL

Principal Display Panel - 207 mL Bottle Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/10/2025

Uses

  • For the treatment of acne
  • Helps keep skin clear of new acne blemishes
  • Helps prevent the development of new acne pimples

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/10/2025

Dist. by: Dickinson Brands Inc.
East Hampton, CT 06424

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/10/2025

Active ingredient

Salicylic Acid (2%)

Purpose

Acne Treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 4/10/2025

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.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/10/2025

Directions

Dispense two pumps onto fingertips and massage on to damp skin. Spread in small circular motion. Then rinse. Use AM and PM. If bothersome drying or peeling occurs, reduce usage to every other day. After acne clears, continue using for preventative care. If desired, follow cleansing with Clear Skin Exfoliating Toner.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/10/2025

Inactive ingredients

1,2-Hexanediol, Benzoic Acid, Butylene Glycol, Ceramide NP, Cocamidopropyl Dimethylamine, Coco-Glucoside, Eucalyptol, Glycerin, Glycolipids, Hamamelis Virginiana Distillate, Hydrogenated Lecithin, Lecithin, Melaleuca Alternifolia (Tea Tree) Flower/Leaf/Stem Extract, Niacinamide, Sucrose Stearate, Water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/10/2025

Questions/more info:

1-888-860-2279 | dickinsons.com

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Dickinsons Original Witch Hazel Clarifying Foam Cleanser - FDA Drug Approval Details