Label: ANTI-ITCH MEDICATED 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 August 25, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzocaine 20%

    Resorcinol 3%

  • Purpose

    External analgesic

    External analgesic 

  • Use

    temporarily relieves itching

  • Warnings

    For external use only

    Allergy Allert

    Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics.

    Avoid contact with eyes

    in case of contact rinse thoroughly and immediately with water.

  • 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

    Apply a finger tip amount (approxiamtely a 1 inch strip) to the affected areas not more than 3 to 4 times daily

    Children under 12 years 

    ask a doctor

  • Other Information:

    questions?

  • Inactive ingredients

    Water, Mineral Oil, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Isopropyl Palmitate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Retinyl Palmitate, Zea Mays (Corn) Oil, Cholecalciferol, Lanolin Alcohol, Fragrance, Methylparaben, Carbomer, Isopropyl Myristate, Isopropyl Stearate, Sodium Sulfite, Triethanolamine, Trisodium EDTA, Maltodextrin

  • Principal Display Panel- Tube 

    CVS          NDC 69842-588-28

    Maximum StrengthAnti-Itch Creme

    NET WT 1 oz. (28 g)

    Principal Display Panel- Tube

    Principal Display Panel- Tube

  • Principal Display Panel- Carton

    CVS       69842-588-28

    MAXIMUM STRENGTH ANTI ITCH CREAM 

    NET WT 1.0 OZ (28g)

    Principal Display Panel- Carton

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH MEDICATED MAXIMUM STRENGTH 
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-588
    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
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-588-281 in 1 CARTON09/30/2021
    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 FINALpart34809/30/2021
    Labeler - CVS Health (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(69842-588)
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