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Vagisil Medicated Wipes (Combe Incorporated)

Available Formats

Dosage Form Package Information Links
CLOTH 12 PACKET in 1 CARTON (11509-0375-1) > 4.7 g in 1 PACKET Label Information

Complete Vagisil Medicated Wipes Information

  • SPL UNCLASSIFIED SECTION

    Vagisil Anti-Itch Medicated Wipes


  • Active Ingredients

    Pramoxine hydrochloride 1% w/w                  


  • Purpose

    External analgesic towelette


  • Use

    • temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

    Stop use and ask a doctor if

    condition worsens, or if symptoms persist for more than 7 days or clear 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

    • adults and children 12 years of age and older: unfold towelette and gently pat or wipe external vaginal area from front to back. Use each towelette only once and then throw away. Apply to affected area not more than 3 to 4 times daily.
    • children under 12 years: consult a doctor

  • Inactive Ingredient

    water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, methylparaben, Fragrance, Ethylparaben, disodium EDTA, PEG-7 glyceryl cocoate, aloe barbadensis leaf juice, tocopheryl (Vitamin E) acetate, zea mays (corn) oil, retinyl (Vitamin A) palmitate, cholecalciferol (Vitamin D),


  • Principal Display Panel

    INSTANT RELIEF

    from intense itch

    Vagisil® 

    1% Pramoxine hydrochloride      

    ANTI-ITCH MEDICATED

    MAXIMUM STRENGTH WIPES

    12 individually wrapped, flushable wipes

    5 in. x 7.28 in. (12.7 cm x 18.5 cm)

    • patented Odor Block protection
    • cleanses while relieving itch

    Principal Display Panel - 12 Count Carton


  • INGREDIENTS AND APPEARANCE
    VAGISIL MEDICATED WIPES 
    pramoxine hydrochloride cloth
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-0375
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11509-0375-1 12 in 1 CARTON
    1 4.7 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part347 06/28/2005
    VAGISIL MEDICATED WIPES 
    pramoxine hydrochloride cloth
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11509-0376
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11509-0376-1 20 in 1 POUCH
    1 4.7 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part347 06/28/2005
    Labeler - Combe Incorporated (002406502)
    Establishment
    Name Address ID/FEI Business Operations
    Combe Laboratories, Inc. 808100197 MANUFACTURE