Label: CVS ADVANCED HEALING- 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 April 26, 2012

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  • ACTIVE INGREDIENT

    Active ingredient                         Purpose
    White Petrolatum 41% .........................Skin protectant
  • PURPOSE


    Uses

    Temporarily protects minor - cuts - scrapes - burns
    Temporarily protects and helps relieve chapped or cracked skin or lips
    Helps protect from the drying effects of wind and cold weather
  • 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.
  • INDICATIONS & USAGE

    Uses

    Temporarily protects minor - cuts - scrapes - burns
    Temporarily protects and helps relieve chapped or cracked skin or lips
    Helps protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For external use only.

    Do not use on -     deep 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 at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

  • INACTIVE INGREDIENT

    Inactive Ingredients ceresin, lanolin alcohol, mineral oil
  • PRINCIPAL DISPLAY PANEL


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  • INGREDIENTS AND APPEARANCE
    CVS ADVANCED HEALING 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-904
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM410 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    CERESIN (UNII: Q1LS2UJO3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-904-52113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/12/2011
    Labeler - CVS (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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