Label: LEADER LIP TREATMENT- petrolatum gel

  • 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 14, 2014

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  • Active ingredient

    Petrolatum, 100%

  • Purpose

    Skin Protectant

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Temporarily protects chapped or cracked lips. Helps protect lips from drying effects of wind and cold weather.

  • 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.

  • Directions

    Apply as needed.

  • Inactive Ingredients

    Flavor

  • Package/Label Principal Display Panel

    Leader Petroleum Jelly Lip Treatment Tube

  • INGREDIENTS AND APPEARANCE
    LEADER LIP TREATMENT 
    petrolatum gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM99.98 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) 0.02 mg  in 1 g
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49781-111-351 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/02/2013
    Labeler - Cardinal Health (Leader) (097537435)
    Registrant - Cardinal Health (Leader) (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(49781-111) , LABEL(49781-111)
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