Label: REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH- 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 September 28, 2016

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  • 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 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. Also, do not use if you have an unusual or abnormal vaginal discharge except under the supervision of 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 and older

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

    children under 12 years

    consult a doctor

  • Other information

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients

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

  • Principal display panel - 28 g Carton Label

    REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH CREAM

    NET WT 1 OZ (28 g)

    label of anti-itch

  • INGREDIENTS AND APPEARANCE
    REXALL FEMININE MAXIMUM STRENGTH ANTI-ITCH 
    benzocaine and resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-415
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CORN OIL (UNII: 8470G57WFM)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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:55910-415-0328 g in 1 TUBE; Type 0: Not a Combination Product09/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/27/2016
    Labeler - Dolgencorp, Inc. (068331990)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-415)
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