Label: CALMAFX MOISTURE BARRIER- menthol, calamine, 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 March 22, 2013

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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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