MedPath

Louis Philippe

Louis Philippe Antiperspirant Deodorant Roll-on

Approved
Approval ID

a9c82c7d-027f-4d35-9ce8-ee0afaecab0d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Omega & Delta Co

DUNS: 090317793

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 Code51048-401
Application NumberM019
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aluminum Chlorohydrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (8)

ALUMINUM CHLOROHYDRATEActive
Quantity: 20 g in 100 mL
Code: HPN8MZW13M
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PPG-15 STEARYL ETHERInactive
Code: 1II18XLS1L
Classification: IACT
STEARETH-2Inactive
Code: V56DFE46J5
Classification: IACT
STEARETH-21Inactive
Code: 53J3F32P58
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
TRICLOSANInactive
Code: 4NM5039Y5X
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/17/2025

Louis Philippe ClassicLouis Philippe Classic

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/27/2025

**Use:**Reduces underarm wetness

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/17/2025

Distributed by:

**Omega & Delta Co., Inc.**

Carolina, P.R. 00984

www.omegadeltaco.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/17/2025

Active Ingredients

Aluminum Chlorohydrate 20%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/17/2025

Purpose

Antiperspirant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/27/2025

**Warnings:**For external use only

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 8/27/2025

**Do not use**on broken skin

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 8/27/2025

Stop useif rash or irritation occurs

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/17/2025

**Ask a doctor before use**if you have kidney disease

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/17/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/17/2025

**Directions:**Apply evenly to underarms only

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/17/2025

**Inactive Ingredients:**Water, PPG-15 Stearyl Ether, Steareth-2, Steareth-21, Fragrance, Disodium EDTA, BHT, Triclosan

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Louis Philippe - FDA Drug Approval Details