Label: ANTI-ITCH- men-phor lotion

  • 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 November 16, 2012

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  • Drug Facts

    Active Ingredient Purpose

    0.5% Camphor Anti-Infective, Anti-Pruritic

    0.5% Menthol Anti-Pruritic

  • Intended Use

    To provide temporary relief for dry

    itching skin, sunburn, insect bites and pruritus

  • Directions

    Apply two or three times daily, or as directed by your physician

  • Warnings

    Avoid contact with eyes.If contact occurs, rinse eyes thoroughly with water.

    If improvement does not occur, or condition worsens after regular use as directed,

    discontinue use and consult a physician.

    Do not use on children under two years of age.

    Do not apply under compresses or bandages

  • Inactive Ingredients

    Purified water, Carbopol, Cetearyl alcohol, Cetyl alcohol, DMDM hydantoin,

    Fragrance, Glycol stearate, PEG-4 Dilaurate, PEG-40 Castor oil, Petrolatum,

    Sodium cetearyl sulfate, Stearic acid, TEA

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Apply two or three times daily

  • PRINCIPAL DISPLAY PANEL

    ldra75

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    men-phor lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-683(NDC:54162-550)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PEG-4 DILAURATE (UNII: KCR71CW036)  
    POLYOXYL 40 CASTOR OIL (UNII: 4ERD2076EF)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHYLAMINE (UNII: VOU728O6AY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-683-82222 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/16/2012
    Labeler - CARDINAL HEALTH (097537435)
    Registrant - GERITREX CORP (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    GERITREX CORP112796248manufacture(37205-683)
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