Label: CVS PHARMACY SENSITIVE MEDICATED CREAM- benzocaine, benzalkonium chloride 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 4, 2017

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  • ACTIVE INGREDIENT


    Active Ingredients

    Benzocaine 5%

    Benzalkonium Chloride 0.13%

    Purpose

    Topical Analgesic

    First Aid Antiseptic

  • Uses

    First aid temporary relief from the discomforts affecting the external area surrounding the vagina:

    • Itching
    • Burning
    • Irritation
    • Skin infections
  • Warnings

    For external use only.

    Do not use if you have unusual or abnormal vaginal discharge except under the supervision of your doctor.

    When using this product

    • Wash hand thoroughly with soap and water before and after use
    • Avoid contact with eyes.
    • If burning sensation occurs and lasts more than a few minutes remove the cream and discontinue use.
    • Do not use more than 1 week unless directed by a doctor

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
    • side effect occur. You may report sude effect to FDA at 1-800-FDA-1088

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately. If in eyes, flush with water for 15 minutes and call a physician.

  • WHEN USING

    • Apply to the affected area.
    • Because the area may already be irritated you could experience a slight burning sensation. If this persists more than a few minutes, remove cream and discontinue use.
    • Wash hand thoroughly with soap and water before and after use.
  • OTHER SAFETY INFORMATION

    Store at room temperature. For lot number and expiration dates see crimp of tube or side of box.

  • INACTIVE INGREDIENT

    Deionized Water, Glycerol Monostearate, Mineral Oil, PEG 100 Stearate, Cetyl Alcohol, Fragrance, Aloe Vera Gel, Lanolin Alcohol, Isopropyl Myristate, Isopropyl Stearate, Isopropyl Palmitate, Triethanolamine, Methylparaben, Propylparaben, Carbomer, Tocopheryl Acetate (Vitamin E), Trisodium HEDTA.

  • Questions or Comments

    1-800-635-3696

  • DOSAGE & ADMINISTRATION

    • Adults and children 2 years and over: Apply to the affected area not more than 3 to 4 times daily.
    • Children under 2 years: Do not use-consult a doctor.
  • PRINCIPAL DISPLAY PANEL

    tube and carton

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  SENSITIVE MEDICATED CREAM
    benzocaine, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-638
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.05 g  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-638-011 in 1 CARTON05/01/2005
    142.5 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 finalpart34805/01/2005
    Labeler - CVS Pharmacy (062312574)
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