Label: CUBA ORIGINAL MENS ROLL ON ANTIPERSPIRANT DEODORANT- aluminum chlorohydrate liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 13, 2010

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  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredient                           Purpose

    Aluminum chlorohydrate 25%      Antiperspirant

  • PURPOSE


    Purpose:
    Antiperspirant
  • INDICATIONS & USAGE

    Uses: Reduces underarm wetness

  • WARNINGS

    WARNINGS

    For external use only. Do not use on broken skin.

  • STOP USE

    Stop use if rash or irritation occurs.

    Ask a doctor before using if you have kidney disease.

  • 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

  • SPL UNCLASSIFIED SECTION

    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

    info@newbrandperfumes.com


    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 1-305-406-23-84
  • PRINCIPAL DISPLAY PANEL

    CUBA ORIGINAL
    by PARFUMS DES CHAMPS
    PROTECTION 24H

    MENS ROLLON
    ANTIPERSPIRANT DEODORANT
    NET 1.7 FL OZ (50ML)
  • PRINCIPAL DISPLAY PANEL

    Cuba_rollon_label

  • INGREDIENTS AND APPEARANCE
    CUBA ORIGINAL MENS ROLL ON ANTIPERSPIRANT DEODORANT 
    aluminum chlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49902-3690
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) (ALUMINUM CHLOROHYDRATE - UNII:HPN8MZW13M) ALUMINUM CHLOROHYDRATE25 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL BENZOATE (UNII: N863NB338G)  
    CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COUMARIN (UNII: A4VZ22K1WT)  
    EUGENOL (UNII: 3T8H1794QW)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49902-3690-050 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35008/31/2010
    Labeler - BB TRADING WORLDWIDE, INC (031675820)
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