Label: VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH- pramoxine hydrochloride cloth

  • NDC Code(s): 11509-5035-1, 11509-5058-1
  • Packager: Combe Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 20, 2020

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  • SPL UNCLASSIFIED SECTION

    VAGISIL Anti-Itch Medicated Wipes

    Drug Facts

  • Active ingredient

    Pramoxine hydrochloride 1% (w/w)

  • Purpose

    External analgesic

  • Use

    temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

  • Stop use and ask 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 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. Do not flush.
    children under 12 yearsconsult a doctor
  • Inactive ingredients

    water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

  • SPL UNCLASSIFIED SECTION

    VAGISIL Maximum Strength Medicated Anti-Itch Wipes

    Drug Facts

  • Active ingredient

    Pramoxine hydrochloride 1% (w/w)

  • Purpose

    External analgesic

  • Use

    Temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

  • Stop use and ask 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 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. Do not flush.
    children under 12 yearsconsult a doctor
  • Other information

    store at room temperature

    discard within 2 months of opening

  • Inactive ingredients

    water, polysorbate 20, glycerin, phenoxyethanol, disodium cocoamphodiacetate, TEA-cocoyl glutamate, ethylparaben, disodium EDTA, methylparaben, fragrance, PEG-7 glyceryl cocoate, aloe barbadensis leaf extract, tocopheryl acetate, maltodextrin

  • Principal Display Panel

    Maximum Strength
    Vagisil    ®

    Medicated Anti-Itch Wipes

    Instant Relief From Intense Itch

    Gynecologist Tested

    Clinically Tested

    • On-the-go relief
    • With Aloe & Vitamin E
    • Patented Odor Block Technology

    12 individually wrapped disposable wipes

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

    Maximum Strength Vagisil® Medicated Anti-Itch Wipes Instant Relief From Intense Itch Gynecologist Tested Clinically Tested • On-the-go relief • With Aloe & Vitamin E • Patented Odor Block Technology 12 individually wrapped disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)

  • Principal Display Panel

    Vagisil®
    Maximum Strength

    Medicated Anti-Itch Wipes

    Gynecologist Tested

    Instant Relief From Intense Itch

    • With Aloe & Vitamin E
    • Patented Odor Block Technology

    20 soft, disposable wipes

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

    Principal Display Panel Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)

    Vagisil® Maximum Strength Medicated Anti-Itch Wipes Gynecologist Tested Instant Relief From Intense Itch • With Aloe & Vitamin E • Patented Odor Block Technology 20 soft, disposable wipes 5 in. x 7.28 in. (12.7 cm x 18.5 cm)

  • INGREDIENTS AND APPEARANCE
    VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    TRIETHANOLAMINE COCOYL GLUTAMATE (UNII: LA19WH54UL)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11509-5035-112 in 1 CARTON06/28/2005
    14.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/28/2005
    VAGISIL ANTI-ITCH MEDICATED WIPES MAXIMUM STRENGTH 
    pramoxine hydrochloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11509-5058
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    TRIETHANOLAMINE COCOYL GLUTAMATE (UNII: LA19WH54UL)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11509-5058-120 in 1 POUCH06/28/2005
    13.4 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/28/2005
    Labeler - Combe Incorporated (002406502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Combe Laboratories, Inc.808100197ANALYSIS(11509-5035, 11509-5058) , LABEL(11509-5035, 11509-5058) , MANUFACTURE(11509-5035, 11509-5058) , PACK(11509-5035, 11509-5058)
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