Label: 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 February 16, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                      Purpose
    White petrolatum
    60.4%......................................Skin protectant
  • PURPOSE


    Active ingredient                 Purpose
    Salicylic Acid
    (0.5%)..............................Acne Medication
    ______________________________________

    Use for the management of acne
  • KEEP OUT OF REACH OF CHILDREN


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

    Uses
    - helps prevent and treat diaper rash
    - helps seal out wetness and protects
    chafed skin due to diaper rash
    -gives temporary relief to chapped,
    cracked skin
    - offers protection from the drying
    effects of wind and cold weather
    - gives temporary protection for minor
    cuts, scrapes and burns
  • WARNINGS

    Warnings
    For external use only.
    _______________________________

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

    Keep product away from eyes.
    _______________________________

    Stop use and ask a doctor if:
    -condition worsens
    -symptoms last more than 7 days; clear
    up and occur again within several days
  • DOSAGE & ADMINISTRATION


    Directions
    -for diaper rash:
      - change soiled, wet diapers
        immediately
      - cleanse diaper area thoroughly
        and allow to dry
      - liberally apply ointment as often as
        necessary, with each diaper change,
        especially at bedtime or whenever
        exposure to wet diapers may be
        prolonged
    - for other uses: apply as needed
    ________________________________

    Other information

    Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • INACTIVE INGREDIENT

    Inactive Ingredients
    cholecalciferol, cocoa butter, fragrance,
    light mineral oil, mineral oil, modified
    lanolin, paraffin, sodium pyruvate,
    sunflower seed oil, Vitamin A palmitate,
    Vitamin E (di-alpha tocopherol and
    di-alpha tocopheryl acetate)
  • PRINCIPAL DISPLAY PANEL

    label


  • INGREDIENTS AND APPEARANCE
    PETROLATUM 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-148
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM600 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-148-2799 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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