Label: MENTHOL AND 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 October 23, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                         Purpose

    Menthol 0.44% v/v                            External Analgesic

                                                              First Aid Antiseptic

                                                              Antipuritic

    Zinc Oxide 20.625% v/v                       Skin Protectant

                                                               Moisture Barrier         

  • Purpose:

    A moisture barrier that prevents and helps heal skin irritations from;

    • urine
    • diarrhea
    • perspiration
    • fistula drainage
    • feeding tube site leakage
    • wound drainage (peri-wound skin)
    • minor burns
    • cuts
    • scrapes
    • itching
  • Warnings:

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Indications & Usage

    • Not for deep or puncture wounds.
    • Avoid contact with eyes.
    • If condition worsens or does not improve within 7 days, consult a doctor
  • Dosage & Administration:

    • Clean skin with mild skin cleanser
    • Pat dry or allow to air dry
    • Apply a thin layer of Calasoothe to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection
  • 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.

  • Inactive Ingredients

    Inactive Ingredients: Calamine, Glycerine, Phenol, Lanolin, Heavy Liquid Paraffin, Sodium Bicarbonate, Thymol, White Soft Paraffin

  • Principal Display Panel

    Principal Display Panel - Ointment

    Blossom1275.jpg

    Cala Ointment

  • INGREDIENTS AND APPEARANCE
    MENTHOL AND ZINC OXIDE  
    menthol and zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61767-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOL (UNII: 339NCG44TV)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61767-234-013.5 g in 1 POUCH
    2NDC:61767-234-0271 g in 1 JAR
    3NDC:61767-234-03113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/11/2014
    Labeler - Blossom Pharmaceuticals (677381470)
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