Label: CALMAFX MOISTURE BARRIER- menthol, ferric oxide red and zinc oxide ointment 

  • NDC Code(s): 75904-3246-0, 75904-3246-3
  • Packager: First Choice Medical Supply
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Menthol 0.45%

    Calamine 2%

    Zinc Oxide 18%

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  • Purpose

    External Analgesic, Skin Protectant

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  • 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
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  • Warnings

    • For external use only.
    • When using this product
    • do not get into eyes.
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  • 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.
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  • 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.
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  • 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.
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  • Other Information

    Store at 15-30°C (59-86°F)

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  • Inactive Ingredients:

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

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  • Questions or Comments?

    First Choice Medical Supply

    127 Interstate Dr.

    Richland, MS 39218

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

    Item # 33433

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  • Images of representative artwork

    CalmafxSachet.jpgSachet calmafxtube.jpgTube

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  • INGREDIENTS AND APPEARANCE
    CALMAFX  MOISTURE BARRIER
    menthol, calamine, zinc oxide ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:75904-3246
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 4.5 mg  in 1 g
    FERRIC OXIDE RED (FERRIC OXIDE RED) FERRIC OXIDE RED 20 mg  in 1 g
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 180 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    EDETATE DISODIUM  
    GLYCERIN  
    LANOLIN  
    METHYLPARABEN  
    MINERAL OIL  
    PETROLATUM  
    PROPYLPARABEN  
    WATER  
    SODIUM BORATE  
    SORBITAN SESQUIOLEATE  
    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)
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