LUVENA FEMININE WIPES (PRAMOXINE HYDROCHLORIDE) CLOTH [LACLEDE, INC.]

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LUVENA FEMININE WIPES (PRAMOXINE HYDROCHLORIDE) CLOTH [LACLEDE, INC.]
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NDC 54897-601-11
Set ID b607f6a7-f2e2-4af8-8ae5-9d66f1b1fb06
Category HUMAN OTC DRUG LABEL
Packager LACLEDE, INC.
Generic Name
Product Class
Product Number
Application Number PART346
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  • Purpose

    External Analgesic Towelette.

  • Active Ingredient

    Pramoxine hydrochloride 1% w/w

  • Uses

    Temporarily relieves itching and burning due to minor skin irritations.

  • Warnings

    For external use only. Store at room temperature.

    Avoid contact with eyes. Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days, or clears up and occur again within a few days.

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Remove cloth from foil pouch. Unfold and gently wipe to clean external vaginal area. Use each towelette only once and then throw away. Use daily whenever desired to be refreshed.

  • Dosage

    Topical use only. Use daily whenever desired to be refreshed.

  • Inactive Ingredients

    Aloe Vera, Benzyl Alcohol, Cucumber Extract, Fragance, Menthyl Lactate, PEG-6 Caprylic/Capric Glyceride, PEG-75 Lanolin, Propylene Glycol, Purified Water, Tea Tree Oil, Witch Hazel, Lactoferrin, Lactoperoxidase, Lysozyme.

  • LUVENA FEMININE WIPES label

    LUVENA FEMININE WIPES label

  • INGREDIENTS AND APPEARANCE
    LUVENA FEMININE WIPES 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54897-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
    PEA (UNII: W4X7H8GYFM)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    LYSOZYME HYDROCHLORIDE (UNII: 4YRW73H69V)  
    LACTOPEROXIDASE BOVINE (UNII: 01UIN5OC49)  
    TALACTOFERRIN ALFA (UNII: 7A055A9QRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54897-601-111500 mg in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/04/2012
    Labeler - LACLEDE, INC. (098835994)
    Registrant - LACLEDE, INC. (098835994)
    Establishment
    NameAddressID/FEIBusiness Operations
    LACLEDE, INC.098835994manufacture(54897-601)
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