Otc - Active Ingredient
DRUG FACTS
Active Ingredient Purpose
Aluminum chlorohydrate 25% Antiperspirant
Cuba Original Ladies Roll On Antiperspirant Deodorant
FDA Label NDC 49902-3942
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bb Trading Worldwide, Inc for the product Cuba Original Ladies Roll On Antiperspirant Deodorant (NDC 49902-3942). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:Antiperspirant
Indications & Usage
Uses: Reduces underarm wetness
Warnings
WARNINGS
For external use only. Do not use on broken skin.
Otc - Stop Use
Stop use if rash or irritation occurs.
Ask a doctor before using if you have kidney disease.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away.
Dosage & Administration
Directions
Apply to underarms only
Inactive Ingredient
Inactive Ingredients
Alpha-isomethyl ionone, Benxyl benzoate, Cinnamyl alcohol, cinnamal, citral, citronellol, coumarin, eugenol, fragrance, geraniol, hydroxy methylpentyl cyclohexane carboxaldehyde, Limonene, Linalool, PPG-15 stearyl Ether, Steareth 20 brij 78, Steareth 2 brij 72, 2-(4-tert butylbenzyl)propionaldehyde, water
Other
Distributed by: BB Trading Worldwide, Inc. 8299 NW 30th Terrace, Miami FL 33122, USA, www.fragluxe.com
Newbrand perfumes, 54 Chausse de Merchtem, 1780 Wemmel, Belgium
CUBA ORIGINAL BY PARFUMS DES CHAMPS IS A TRADEMARK OF PC DESIGN
in France: No 103704186
In E.U.: 008806457
In USA No 2248555
Made in France
To report a Serious or Adverse Event Contact 1-305-406-23-84Package Label.Principal Display Panel
CUBA ORIGINAL by PARFUMS DES CHAMPSPROTECTION 24HLADIES ROLLONANTIPERSPIRANT DEODORANTNET 1.7 FL OZ (50ML)
Cuba_rollon_label_ladies (Cubawomens)
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