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CalmaFX (First Choice Medical Supply)

Available Formats

Dosage Form Package Information Links
OINTMENT 113 g in 1 TUBE (75904-3246-0) Label Information
OINTMENT 5 g in 1 POUCH (75904-3246-3) Label Information

Complete CalmaFX Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:75904-3246
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 4.5 mg  in 1 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 20 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 180 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75904-3246-3 5 g in 1 POUCH
    2 NDC:75904-3246-0 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 02/28/2011
    Labeler - First Choice Medical Supply (117734405)
    Registrant - Summit Industries, Inc. (003279189)
    Establishment
    Name Address ID/FEI Business Operations
    Summit Industries, Inc. 003279189 manufacture(75904-3246)