FDA.reportPublic FDA data

Ralph Lauren

Manufacturer
L'Oreal USA Products Inc | L'Oreal USA, Inc. | Les Emballages Facoteck Inc.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
legacy-cache
Hydrated at
2026-08-01 21:16:13

Label at a glance#

ProductRalph Lauren Romance Antiperspirant Deodorant
Active ingredientAluminum Zirconium Tetrachlorohydrex Gly
Label structure8 sections

Dosage and administration

apply to underarms only

Label contents#

Full prescribing information#

Use

INDICATIONS & USAGE SECTION

reduces underarm wetness

Purpose

OTC - PURPOSE SECTION

Antiperspirant

Warnings

WARNINGS SECTION

For external use only

Do not use on broken skin

Stop use if rash or irritation occurs

Ask a doctor before use if you have kidney disease

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply to underarms only

Inactive ingredients

INACTIVE INGREDIENT SECTION

isopropyl palmitate, dimethicone, stearyl alcohol, hydrogenated castor oil, aluminum starch octenylsuccinate, PEG-8 distearate, PPG-14 butyl ether, fragrance, nylon-12, synthetic wax, water, disteardimonium hectorite, calcium hydroxide, citronellol, hydroxycitronellal, benzyl alcohol, linalool, geraniol, limonene, alpha-isomethyl ionone, hexyl cinnamal, coumarin

Questions or Comments?

OTC - QUESTIONS SECTION

Contact: 1-800-422-2360

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a labelimage of a label

image of a label
image of a label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-479RALPH LAUREN ROMANCE ANTIPERSPIRANT DEODORANT (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY) STICK [L'OREAL USA PRODUCTS INC]13Legacy NDC20240103_8dee7c1c-9e65-49b6-b749-b13eac7a253a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aluminum Zirconium Tetrachlorohydrex GlyACTIVE INGREDIENT8O386558JE5
Aluminum Zirconium Tetrachlorohydrex GlyACTIVE MOIETY8O386558JE5

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-47949967-479-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aluminum Zirconium Tetrachlorohydrex Gly8O386558JEACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIMETHICONE92RU3N3Y1OIACT
STEARYL ALCOHOL2KR89I4H1YIACT
NYLON-12446U8J075BIACT

Source Document#

Source XML · Source PDF

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
5613ccdf-a5d4-48b6-b073-6a9e15a189438dee7c1c-9e65-49b6-b749-b13eac7a253a2024-01-02WarningsExact identifier
spl id: 5613ccdf-a5d4-48b6-b073-6a9e15a18943
spl set id: 8dee7c1c-9e65-49b6-b749-b13eac7a253a

Reported adverse events (FAERS/openFDA)#

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