QUALITY CHOICE VAGINAL ANTI-ITCH MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION (CDMA)]

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  • QUALITY CHOICE VAGINAL ANTI-ITCH MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION (CDMA)]

QUALITY CHOICE VAGINAL ANTI-ITCH MAXIMUM STRENGTH (BENZOCAINE AND RESORCINOL) CREAM [CHAIN DRUG MARKETING ASSOCIATION (CDMA)]
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NDC 63868-965-01
Set ID c86d96ac-9145-4b8e-a044-4338474cef00
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association (CDMA)
Generic Name
Product Class
Product Number
Application Number PART348
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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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