Label: OPTIMV ANTI-ITCH MAXIMUM STRENGTH- benzocaine, resorcinol cream

  • NDC Code(s): 55758-300-01, 55758-300-07
  • Packager: Pharmadel LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Drug Facts

    Drug Facts

  • Active ingredients

    Benzocaine 20%

    Resorcinol 3%

    Active ingreditents Purpose
    Benzociane 20% ...............External analgesic
    Resorcinol 3% ...................External analgesic

  • Use

    Temporarily relieves itching.

  • Warnings

    For external use only. Avoid contact with the eyes.

    Do not use

    • this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other –caine anesthetics
    • over large areas of the body
    • if you have unusual or abnormal vaginal discharge except under the supervision of a physician

    Stop use and ask doctor if

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and occur again within a few days

    If pregnant or breastfeeding,

    seek professional advice before taking this product.

    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 to the affected areas not more than 3 to 4 times daily
    • children under 12 years: ask a doctor

  • Other Information

    • do not use if foil seal under cap is punctured or missing
    • store at 20°-25°C (68°F-77°F)
  • Inactive ingredients

    aloe, carbomer 1342, cetyl alcohol, cholecalciferol (vitamin D), corn oil, dl-alpha- tocopherol (vitamin E), edetate disodium, fragrance, glyceryl monostearate, isopropyl myristate, isopropyl palmitate, lanolin, methylparaben, mineral oil, PEG-100 stearate, propylene glycol, retinol (vitamin A), stearic acid, stearyl alcohol, trolamine, water.

  • Principal Display Panel

    PDP 1oz Optim V AI Cream

  • INGREDIENTS AND APPEARANCE
    OPTIMV ANTI-ITCH  MAXIMUM STRENGTH
    benzocaine, resorcinol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-300
    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
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    RETINOL (UNII: G2SH0XKK91)  
    CORN OIL (UNII: 8470G57WFM)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-300-071 in 1 CARTON06/01/202206/01/2022
    120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:55758-300-011 in 1 CARTON06/01/2022
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2022
    Labeler - Pharmadel LLC (030129680)
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