Label: FRAICHEUR VERVEINE ANTIPERSPIRANT AND DEODORANT ROLL-ON- aluminum sesquichlorohydrate lotion

  • 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 23, 2010

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  • ACTIVE INGREDIENT

    Active ingredient
    Aluminum sesquichlorohydrate 15%

  • PURPOSE

    Purpose
    Antiperspirant

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Use
    Reduces underarm perspiration

  • WARNINGS

    Warnings:
    For external use only.     Ask a doctor before use if you have kidney disease. Do not use on broken skin. Stop use if rash or irritation occurs.

  • DOSAGE & ADMINISTRATION

    Directions:
    Apply as needed to underarms

  • INACTIVE INGREDIENT

    Non-medicinal ingredients: WATER • CYCLOPENTASILOXANE • PPG-15 STEARYL ETHER • CETEARYL ALCOHOL • DICAPRYLYL CARBONATE • DIMETHICONE • CETEARETH-33 • FRAGRANCE • CETYL ALCOHOL

  • PRINCIPAL DISPLAY PANEL

    Fraicheur verveine

    Antiperspirant and deodorant roll-on

    60 ml - 2.0 fl. oz.




    Front label

    Back label

  • INGREDIENTS AND APPEARANCE
    FRAICHEUR VERVEINE ANTIPERSPIRANT AND DEODORANT ROLL-ON 
    aluminum sesquichlorohydrate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63505-157
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 63.65 mL  in 100 mL
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 8 mL  in 100 mL
    ETHER (UNII: 0F5N573A2Y) 4 mL  in 100 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 3.6 mL  in 100 mL
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 2 mL  in 100 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) 2 mL  in 100 mL
    CETEARETH-33 (UNII: R42C2O714B) 0.9 mL  in 100 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.35 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63505-157-0860 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35007/01/2008
    Labeler - YVES ROCHER NORTH AMERICA INC (201908311)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yves Rocher North America Inc. DBA Laboratoire de biologie vegetal Yves Rocher347509127manufacture
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