MedPath

Dawn Ultra Antibacterial Hand

Dawn Ultra Antibacterial Hand Orange Scent

Approved
Approval ID

b440e526-83c2-45b7-9c45-f95151216000

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 26, 2025

Manufacturers
FDA

The Procter & Gamble Manufacturing Company

DUNS: 004238200

Products 1

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

Chloroxylenol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37000-617
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Chloroxylenol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 26, 2025
FDA Product Classification

INGREDIENTS (14)

TETRASODIUM GLUTAMATE DIACETATEInactive
Code: 5EHL50I4MY
Classification: IACT
DECETH-8Inactive
Code: 19FQ96EA8Q
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PPG-26Inactive
Code: V86KZL3H2Z
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8W
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CHLOROXYLENOLActive
Quantity: 0.3 g in 100 mL
Code: 0F32U78V2Q
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
C9-11 PARETH-8Inactive
Code: 80E6PSE1XL
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/2/2018

PRINCIPAL DISPLAY PANEL - 1.12L (1.18 QT) Bottle Label

DAWN ®
** ULTRA**

CHLOROXYLENOL ANTIBACTERIAL HAND SOAP

ORANGE SCENT

*VS DAWN NON-CONCENTRATED

DISHWASHING LIQUID

1.12L (1.18 QT) 38 FL OZ

Dawn

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/19/2014

Use

  • for handwashing to decrease bacteria on the skin

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/19/2014

Distributed byPROCTER & GAMBLE,
CINCINNATI, OH 45202

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/19/2014

Active ingredient

Chloroxylenol 0.30%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/19/2014

Purpose

Antibacterial hand soap

WARNINGS SECTION

LOINC: 34071-1Updated: 6/19/2014

Warnings

For external use only

Keep out of reach of children. In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/19/2014

Directions

  • wet hands and forearms. Apply 5 ml or palmful to hands and forearms. Scrub thoroughly for 30 sec. and rinse.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/1/2023

Inactive ingredients

Water, sodium lauryl sulfate, lauramine oxide, alcohol denat., phenoxyethanol, tetrasodium glutamate diacetate, sodiumchloride, fragrance, deceth-8, C9-11 alketh-8, PPG-26, sodium hydroxide, yellow 5, red 33

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/19/2014

Questions?

1-800-725-3296

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