Label: BALMEX MULTI-PURPOSE- petrolatum 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 November 13, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Petrolatum 51.1%

    		Skin protectant
  • Uses

    • temporarily protects minor
      • cuts
      • scrapes
      • burns
    • temporarily protects and helps relieve chapped or cracked skin
    • helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness 
  • Warnings

    For external use only

    When using this product

    • do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • apply as needed
    • change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • Other information

    • do not use if quality seal is broken
    • see bottom of tube for lot number and expiration date
  • STORAGE AND HANDLING

  • Inactive ingredients

    acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)

  • Questions?

    1-833-389-9450

  • SPL UNCLASSIFIED SECTION

    Distributed by RANDOB LABS LTD.
    Box 440, Cornwall, NY 12518

  • PRINCIPAL DISPLAY PANEL - 99 g Tube Label

    NEW LOOK-SAME PRODUCT

    Balmex®
    MULTI-PURPOSE

    HEALING OINTMENT
    Skin Protectant-Petrolatum 51.1%

    From diaper rash to
    chapped, chafed skin

    ✔
    Heals, protects & soothes
    ✔
    7 healing moisturizers
    plus Vitamin A & Vitamin D
    ✔
    Clear and easy to apply

    Pediatrician Recommended

    NET WT
    3.5 OZ
    (99 g)

    Principal Display Panel - 99 g Tube Label
  • INGREDIENTS AND APPEARANCE
    BALMEX MULTI-PURPOSE 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum511 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Vachellia Farnesiana Flower (UNII: 8487B3MG6D)  
    Allantoin (UNII: 344S277G0Z)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Chamomile (UNII: FGL3685T2X)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Dimethicone 200 (UNII: RGS4T2AS00)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
    Lavandula Angustifolia Subsp. Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
    Mineral Oil (UNII: T5L8T28FGP)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Rosemary (UNII: IJ67X351P9)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    .alpha.-tocopherol Acetate, Dl- (UNII: WR1WPI7EW8)  
    Corn Oil (UNII: 8470G57WFM)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-450-3599 g in 1 TUBE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/27/2015
    Labeler - Randob Labs,Ltd. (061995007)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK HOLDCO COMPANY INC.243547333MANUFACTURE(52412-450)
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