CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]

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CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]
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NDC 75904-3246-0, 75904-3246-3
Set ID 7b52374e-1119-4145-b87b-96b7212fdc3e
Category HUMAN OTC DRUG LABEL
Packager First Choice Medical Supply
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredients

    Menthol 0.45%

    Calamine 2%

    Zinc Oxide 18%

  • Purpose

    External Analgesic, Skin Protectant

  • Uses

    A moisture barrier that prevents and helps protect skin irritations from

    • urine
    • diarrhea
    • perspiration
    • fistula drainage
    • feeding tube site leakage
    • wound drainage
    • minor burns
    • cuts
    • scrapes
    • itching
  • Warnings

    • For external use only.
    • When using this product
    • do not get into eyes.
  • ASK DOCTOR

    Stop use and ask doctor if :

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    When practical, gently cleanse and dry area.

    • Adults: Apply externally to affected area up to 6 times daily or after each incontinent episode or diaper change.
    • Children under 12 years: Consult a doctor.
  • Other Information

    Store at 15-30°C (59-86°F)

  • Inactive Ingredients:

    Beeswax, Disodium EDTA, Glycerin, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylparaben, Purified Water, Sodium Borate, Sorbitan Sesquioleate

  • Questions or Comments?

    First Choice Medical Supply

    127 Interstate Dr.

    Richland, MS 39218

    800-809-4556 or visit www.fcms.com

    Item # 33433

  • Images of representative artwork

    CalmafxSachet.jpgSachet calmafxtube.jpgTube

  • INGREDIENTS AND APPEARANCE
    CALMAFX  MOISTURE BARRIER
    menthol, calamine, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75904-3246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.5 mg  in 1 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED20 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE180 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75904-3246-35 g in 1 POUCH
    2NDC:75904-3246-0113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/28/2011
    Labeler - First Choice Medical Supply (117734405)
    Registrant - Summit Industries, Inc. (003279189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Summit Industries, Inc.003279189manufacture(75904-3246)
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