Label: VAGISIL ANTI ITCH ORIGINAL STRENGTH- benzocaine and resorcinol cream VAGISIL ANTI ITCH MAXIMUM STRENGTH- benzocaine and resorcinol cream 

  • Label RSS
  • NDC Code(s): 11509-0360-1, 11509-0360-2, 11509-0372-1
  • Packager: Combe Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/09

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  • SPL UNCLASSIFIED SECTION

    Vagisil Anti-Itch Creme Original Strength

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  • Active Ingredients

    Benzocaine 5%                                    

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  • Purpose

    External analgesic

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  • Active Ingredients

    Resorcinol 2%                                    

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  • Purpose

    External analgesic

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  • Use

    • temporarily relieves itching
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  • 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

    Do not apply over large areas of the body

    Keep out of reach of children

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

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  • Directions

    • adults and children 2 years and older: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily
    • children under 2 years: consult a doctor
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  • Inactive ingredients  

    water, cetyl alcohol, glyceryl stearate, PEG-100 stearate, mineral oil, isopropyl palmitate, aloe barbadensis leaf juice, tocopheryl acetate, retinyl palmitate, zea mays (corn) oil, cholecalciferol, lanolin alcohol, fragrance, methylparaben, carbomer, isopropyl myristate, isopropyl stearate, sodium sulfite, triethanolamine, trisodium HEDTA



    Vagisil Anti-Itch Creme Maximum Strength 

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  • Active Ingredients

    Benzocaine 20%                                    

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  • Purpose

    External analgesic

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  • Active Ingredients

    Resorcinol 3%                                    

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  • Purpose

    External analgesic

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  • Use

    • temporarily relieves itching
    Close
  • 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

    Do not apply over large areas of the body

    Keep out of reach of children

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

    Close
  • Directions

    • adults and children 12 years and older: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily
    • children under 12 years: consult a doctor
    Close
  • Inactive ingredients

    water, mineral oil, cetyl alcohol, propylene glycol, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, aloe barbadensis leaf juice, tocopheryl acetate, retinyl palmitate, zea mays (corn) oil, cholecalciferol, lanolin alcohol, fragrance, methylparaben, carbomer, isopropyl myristate, isopropyl stearate, sodium sulfite, triethanolamine, trisodium HEDTA

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  • Principal Display Panel

    Vagisil®

    ANTI-ITCH CREME

    ORIGINAL STRENGTH       NET WT. 1 OZ (28 g)

    Principal Display Panel - Original Strength 1oz

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  • Principal Display Panel

    Vagisil®

    ANTI-ITCH CREME

    MAXIMUM STRENGTH       NET WT. 1 OZ (28 g)

    Principal Display Panel - Maximum Strength 1oz

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  • INGREDIENTS AND APPEARANCE
    VAGISIL ANTI ITCH ORIGINAL STRENGTH 
    benzocaine and resorcinol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11509-0360
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 50 mg  in 1 g
    RESORCINOL (RESORCINOL) RESORCINOL 20 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CETYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    POLYOXYL 100 STEARATE  
    MINERAL OIL  
    ISOPROPYL PALMITATE  
    ALOE VERA LEAF  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    CORN OIL  
    CHOLECALCIFEROL  
    METHYLPARABEN  
    ISOPROPYL MYRISTATE  
    SODIUM SULFITE  
    TROLAMINE  
    TRISODIUM HEDTA  
    VITAMIN A PALMITATE  
    CARBOMER HOMOPOLYMER TYPE C  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11509-0360-1 1 in 1 CARTON
    1 28 g in 1 TUBE
    2 NDC:11509-0360-2 1 in 1 CARTON
    2 56 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 08/01/1974
    VAGISIL ANTI ITCH MAXIMUM STRENGTH 
    benzocaine and resorcinol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11509-0372
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 g
    RESORCINOL (RESORCINOL) RESORCINOL 30 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    CETYL ALCOHOL  
    GLYCERYL MONOSTEARATE  
    POLYOXYL 100 STEARATE  
    MINERAL OIL  
    ISOPROPYL PALMITATE  
    ALOE VERA LEAF  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    CORN OIL  
    CHOLECALCIFEROL  
    METHYLPARABEN  
    ISOPROPYL MYRISTATE  
    SODIUM SULFITE  
    TROLAMINE  
    TRISODIUM HEDTA  
    VITAMIN A PALMITATE  
    CARBOMER HOMOPOLYMER TYPE C  
    PROPYLENE GLYCOL  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11509-0372-1 1 in 1 CARTON
    1 28 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 08/01/1974
    Labeler - Combe Incorporated (002406502)
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