Label: QUALITY CHOICE VAGINAL ANTI-ITCH MAXIMUM STRENGTH- benzocaine and resorcinol cream

  • 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 January 24, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients:

    Benzocaine 20%

    Resorcinol 3%

  • Purpose

    External analgesic

    External analgesic

  • Use:

    temporarily relieves itching.

  • Warnings

    For external use only

    When using this product avoid contact with the 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, discontinue use of this product and consult a physician.

    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.

  • Directions:

    Adults and Children 12 years of age and older

     
    apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily

    Children under 12 years

     
    ask a doctor
  • Other information

    store at 20°- 25°C (68°- 77°F)

  • Inactive ingredients

    purified water, mineral oil, isopropyl palmitate, cetyl alcohol, PEG-100 stearate, glyceryl stearate, isopropyl myristate, lanolin, methyl-4 hydroxybenzoate, carbomer, fragrance, disodium EDTA, triethanolamine, propylene glycol, stearic acid corn oil, stearyl alcohol, vitamin A, E & D, aloe vera gel.

  • Principal Display Panel - 1 oz. Carton Label

    QC®

    QUALITY

    CHOICE

    *Compare to active
    ingredients in VAGISIL    ®
    Maximum Strength

    Maximum Strength

    Vaginal Anti-Itch Cream

    Medicated

    20% Benzocaine | Resorcinol 3%

    Long-Lasting Relief from:

    Every Day Itching and Irritating Vaginal Conditions

    Relieves Every Day Itch

    QC®

    QUALITY

    CHOICE

    Vaginal Anti-Itch Cream

    Maximum Strength

    1 OZ NET WT (28.4g)

    Principal Display Panel - 1 oz. Carton Label
  • Principal Display Panel - 1 oz. Tube Label

    QC®

    QUALITY

    CHOICE

    *Compare to active ingredients in
    VAGISIL    ® Maximum Strength

    Vaginal Anti-Itch Cream

    Maximum Strength

    20% Benzocaine | Resorcinol 3%

    Long-Lasting Relief from:

    Every Day Itching and Irritating Vaginal Conditions

    1 OZ NET WT (28.4g)

    Principal Display Panel - 1 oz. Tube Label
  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE VAGINAL ANTI-ITCH   MAXIMUM STRENGTH
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-965
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Lanolin (UNII: 7EV65EAW6H)  
    Potassium Methylparaben (UNII: M64U971IB0)  
    Mineral Oil (UNII: T5L8T28FGP)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Trolamine (UNII: 9O3K93S3TK)  
    Vitamin A (UNII: 81G40H8B0T)  
    Vitamin D (UNII: 9VU1KI44GP)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-965-011 in 1 CARTON04/28/2014
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/28/2014
    Labeler - Chain Drug Marketing Association (CDMA) (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Essentials947484713MANUFACTURE(63868-965)
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