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Antiperspirant Deodorant Clean Powder 2oz

Antiperspirant Deodorant Clean Powder 2oz

Approved
Approval ID

233a7032-544f-9e16-e063-6394a90a00b3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 28, 2025

Manufacturers
FDA

Rejoice International Corp.

DUNS: 078741245

Products 1

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

Aluminum Chlorohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57337-172
Application NumberM019
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aluminum Chlorohydrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 28, 2025
FDA Product Classification

INGREDIENTS (10)

PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ALUMINUM CHLOROHYDRATEActive
Quantity: 19 g in 100 g
Code: HPN8MZW13M
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CYCLOMETHICONE 5Inactive
Code: 0THT5PCI0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/4/2024

label

label

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/4/2024

Use

Reduces underarm wetness and perspiration.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/4/2024

Active ingredient

Aluminum Chlorohydrate 19%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/4/2024

Purpose

Antiperspirant

WARNINGS SECTION

LOINC: 34071-1Updated: 10/4/2024

Warnings

For external use only

Do not use

Do not use on broken or irritated skin.

Stop use and ask a doctor if

Stop use and ask a doctor if irritation or rash develops.

Ask a doctor before use if

Ask a doctor before use if you have kidney disease.

Keep out of reach of children

If swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/4/2024

Directions

Remove cap. Turn dial to raise product. Apply evenly to underarm only. Replace cap after use.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/4/2024

Inactive ingredients

Mineral Oil

Cetearyl Alcohol

Talc

Cyclopentasiloxane

Isopropyl Myristate

Hydrogenated Castor Oil

Petrolatum

Corn Starch Modified

Fragrance

Sodium Bicarbonate

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Antiperspirant Deodorant Clean Powder 2oz - FDA Drug Approval Details