MedPath

ProCure Antiperspirant and Deodorant

Approved
Approval ID

39d630ac-86ad-68a1-e063-6394a90a4102

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 13, 2025

Manufacturers
FDA

Twin Med LLC

DUNS: 009579330

Products 1

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

Aluminum Sesquichlorohydrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55681-022
Application NumberM019
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aluminum Sesquichlorohydrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 13, 2025
FDA Product Classification

INGREDIENTS (5)

ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PEG-40 CASTOR OILInactive
Code: 4ERD2076EF
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ALUMINUM SESQUICHLOROHYDRATEActive
Quantity: 15 g in 100 mL
Code: UCN889409V
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/14/2025

PCDS04 Image

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/14/2025

Use

Use reduces underarm wetness

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/14/2025

Active Ingredient

Aluminum Sesquichlorohydrate 15%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/14/2025

Purpose

Antiperspirant

WARNINGS SECTION

LOINC: 34071-1Updated: 7/14/2025

Warnings

Warnings

For external use only

Do not use

Do not useon broken skin

Stop use and ask a doctor

Stop use and ask a doctor if rash or irritation occurs

Ask a doctor before use

Ask a doctor before useif you have kidney disease

Keep out of reach of children

Keep out of reach of children. If swallowed, contact a physician or poison control center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/14/2025

Directions

Directions

  • Apply to underarms only
  • Hold in an upright position about 6 inches from underarm and spray

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/14/2025

Inactive Ingredients

Inactive Ingredients

Water, Isopropyl Alcohol, Propylene Glycol, Fragrance, PEG 40 Castor Oil, Phenoxyethanol

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