Label: CALMODROX- menthol, zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 12, 2015

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  • Drug Facts

    Active Ingredient                       Purpose

    Menthol 0.44%                     External analgesic

                                               First aid antiseptic antipruritic

    Zinc Oxide 20.0%                 Skin protectant/moisture barrier

  • Uses

    A moisture barrier that prevents and helps heal skin irritation from Urine, diarrhea, perspiration, fistula drainge, feeding tube site leakage, wound drainage (peri-wound skin), minor burns, cuts, scrapes, itching

  • Directions

    Cleanse skin gently with mild skin cleanser. Pet dry or allow to air dry. Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection

  • Warnings

    FOR EXTERNAL USE ONLY

    Not for deep or puncture wounds

    Avoid contact with eyes

    If condition worsens or does not improve within 7 days, consult a doctor

  • Inactive Ingredients

    Calamine, DMDM Hydantoin, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Phenol, Propylparaben, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearyl Alcohol, Sorbitan Sesquioleate, Sodium bicarbonate and Thymol

  • KEEP OUT OF REACH OF CHILDREN

    In the event of accidental ingestion contact a Poison Control Center right away

  • Storage

    Store at room temperature 15°-30°C (59°-86°F)

  • DOSAGE & ADMINISTRATION

    Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily.

  • PRINCIPAL DISPLAY PANEL

    Label of Tube

  • INGREDIENTS AND APPEARANCE
    CALMODROX 
    menthol, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-219-04113 g in 1 TUBE01/22/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/22/2015
    Labeler - Geritrex Corp (112796248)
    Registrant - Geritrex Corp (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex Corp112796248manufacture(54162-219)
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