FDA.reportPublic FDA data

DawnMist Antiperspirant

Manufacturer
Dukal LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:19

Label at a glance#

ProductDawnMist Antiperspirant
Active ingredientALUMINUM CHLOROHYDRATE
Label structure6 sections

Dosage and administration

Apply to underarms only.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum Chlorohydrate 4.5%

Purpose

OTC - PURPOSE SECTION

Antiperspirant

Use

INDICATIONS & USAGE SECTION

Reduces underarm perspiration

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use on broken skin

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have kidney disease.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to underarms only.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Cetylstearyl Alcohol, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Fragrance, Glycerin, Glyceryl stearate, Hydroxyethylcellulose, Methylparaben, Mineral Oil, Propylparaben, Sorbitan Monostearate, Stearic acid, Triethylamine, Tween-60, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DawnMist

Roll-On

Antiperspirant

Fresh Scent

NDC 65517-2031-1

Dukal

1.5FL.OZ. (44ml)

RD15RD15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2031-1DawnMist Antiperspirant44 mL in 1 BOTTLELOTION442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2031DAWNMIST ANTIPERSPIRANT (ALUMINUM CHLOROHYDRATE) LOTION [DUKAL LLC]2Current NDC, 1 package rows20241222_1e17daf8-075e-e331-e063-6294a90ad11c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65517-203165517-2031-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
ALUMINUM CHLOROHYDRATEHPN8MZW13MACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
TRIETHYLAMINEVOU728O6AYIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MINERAL OILT5L8T28FGPIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
METHYLPARABENA2I8C7HI9TIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT

Source Document#

Source XML

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
DawnMist AntiperspirantALUMINUM CHLOROHYDRATEDukal LLC1e17daf8-075e-e331-e063-6294a90ad11c2024-12-19WarningsExact identifier
ndc (package): 65517-2031-1
ndc (product): 65517-2031
ndc11 (package): 65517203101
spl id: 29a89490-b70d-4a41-e063-6294a90a90ea
spl set id: 1e17daf8-075e-e331-e063-6294a90ad11c

Reported adverse events (FAERS/openFDA)#

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