MedPath

NYU Langone Health Deodorant

Approved
Approval ID

3ee203ab-6a12-fc2d-e063-6294a90ae3d8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Guangdong Aimu Biological Technology Co., Ltd

DUNS: 712647107

Products 1

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

POTASSIUM ALUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83566-559
Application NumberM019
Product Classification
M
Marketing Category
C200263
G
Generic Name
POTASSIUM ALUM
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (9)

GLYCERYL CAPRYLATEInactive
Code: TM2TZD4G4A
Classification: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM CHLOROHYDRATEActive
Quantity: 15 g in 100 mL
Code: HPN8MZW13M
Classification: ACTIB
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SYNTHETIC WAX (1200 MW)Inactive
Code: Q3Z4BCH099
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

Product label

Label.

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/16/2025

Uses

Step1:Before using the deodorant, clean the armpit area with clean water or body wash to ensure the skin is clean

Step2:Apply the deodorant directly under the armpits and evenly cover the skin surface.

Step3:After applying, wait for a few minutes to allow the deodorizing stick to dry completely to ensure that its active ingredients can take effect.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/16/2025

Active ingredients

POTASSIUM ALUM 15%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

Inactive ingredients

ETHYLHEXYL PALMITATE 26.6%
GLYCERYL CAPRYLATE 20%
CYCLOHEXASILOXANE 15%
OZOKERITE 10%
CORN STARCH 5%
SYNTHETIC WAX 5%
MICROCRYSTALLINE WAX 3%
PHENOXYETHANOL 0.4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/16/2025

Purpose

remove ordor

WARNINGS SECTION

LOINC: 34071-1Updated: 9/16/2025

Warnings

For external use only.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/16/2025

Stop Use

Stop use and ask doctor if rash occurs.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/16/2025

Do Not Use

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/16/2025

When Using

When using this product keep out of eyes. Rinse with wate to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/16/2025

Keep Out Of Reach Of Children

Keep out of reach of children. lf swallowed, getmedical help or contact
Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/16/2025

Dosage & administration

Squeeze out an appropriate amount of deodorant and spread

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NYU Langone Health Deodorant - FDA Drug Approval Details