Label: PETROLATUM, LANOLIN ointment

  • Category: HUMAN OTC DRUG LABEL

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 February 16, 2011

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  • ACTIVE INGREDIENT


    Active ingredients                             Purpose

    Lanolin 15.5%..>>>>...................................Skin Protectant
    Petrolatum 53.4%.......................................Skin protectant
  • PURPOSE


    Active ingredients                             Purpose

    Lanolin 15.5%..>>>>...................................Skin Protectant
    Petrolatum 53.4%.......................................Skin protectant
    ______________________________________

    Uses

    - temporarily protects minor: - cuts - scrapes - burns
    - temporarliy protects and helps relieved chapped, chafed or cracked skin and lips
    - helps protect from the drying effects of wind and cold weather 
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of the reach of children. If swallowed, get medical help or contact
    a Poison Control Center right away.
  • INDICATIONS & USAGE


    Uses

    -     temporarily protects minor: - cuts - scrapes - burns
    - temporarliy protects and helps relieved chapped, chafed or cracked skin and lips
    - helps protect from the drying effects of wind and cold weather
  • WARNINGS


    Warnings

    For external use only.
    _______________________________

    Do not use on:
    - Deep or puncture wounds - animal bites - serious burns
    _______________________________

    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

    __________________________________

    Keep out of reach of Children. If swallowed, get medical help or
    contact a Poison Control Center right away
  • DOSAGE & ADMINISTRATION


    Directions
    - apply as needed
    ________________________________

    Other information

    Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
  • INACTIVE INGREDIENT


    Inactive Ingredients cod liver oil (contains vitamin A and vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin.
  • PRINCIPAL DISPLAY PANEL

    c


  • INGREDIENTS AND APPEARANCE
    PETROLATUM, LANOLIN 
    petrolatum, lanolin ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.534 g  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN.155 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-068-4142.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/19/2009
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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