Label: ANTI-ITCH REGULAR STRENGTH- benzocaine and resorcinol cream

  • Category: HUMAN OTC DRUG LABEL

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 22, 2022

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  • Active ingredients

    Benzocaine 5%

    Resorcinol 2%

  • Purpose

    External Analgesic

    External Analgesic

  • Use

    Temporarily relieves itching

  • Warnings

    For external use only

    Avoid contact with eyes

    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.

    Do not apply over large areas of the body.

    Do not use if allergic to any of the ingredients

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

  • 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.
    • clean nozzle of tube by wiping thoroughly before replacing cap. Keep cap tightly closed between uses.

    children under 12 years

    • consult a doctor
  • Other information

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    aloe barbadensis leaf extract, carbomer, cetyl alcohol, cholecalciferol, glyceryl stearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinyl palmitate, sodium hydroxide, sodium sulfite, tocopheryl acetate, trisodium  HEDTA, water

  • Questions or comments

    1-800-WALGREEN (1-800-925-4733)

  • Principal display panel - 28 g Carton Label

    NDC 0363-0621-02

    REGULAR STRENGTH

    Anti-Itch Cream

    Pain Relieving Cream

    NET WT 1 OZ (28 g)

    label of anti-itch
  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH   REGULAR STRENGTH
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0621
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0621-021 in 1 CARTON01/09/2020
    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 finalpart34601/09/2020
    Labeler - Walgreens (008965063)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(0363-0621)