CALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]

CALADROX (MENTHOL, ZINC OXIDE) OINTMENT [GERITREX LLC]
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NDC 54162-229-04
Set ID 0fb20544-54bd-4f7a-8372-8a4dd1d79d21
Category HUMAN OTC DRUG LABEL
Packager Geritrex LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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. Pat dry or allow to air dry. Apply a thin layer of Caladrox 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 Caladrox Ointment to reddened or irritated skin 2-4 times daily.

  • PRINCIPAL DISPLAY PANEL

    Label of Tube

  • INGREDIENTS AND APPEARANCE
    CALADROX 
    menthol, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-229
    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 CATION - UNII:13S1S8SF37) ZINC CATION20 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:54162-229-04113 g in 1 TUBE; Type 0: Not a Combination Product09/29/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/29/2015
    Labeler - Geritrex LLC (112796248)
    Registrant - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-229)