Label: WHITE PETROLATUM- cheryllee md sensitive skin care truelipids truelips lip balm ointment

  • NDC Code(s): 61387-250-01, 61387-250-02
  • Packager: Claridei Laboratories, Inc.
  • 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 July 20, 2023

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  • Active Ingredient

    White Petrolatum 50%

  • Purpose

    Skin Protectant (ointment)

  • Uses

    • helps prevent and temporarily protect chafed, chapped, cracked lips
    • helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    Keep out of reach of children

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

  • Directions

    • ​apply as needed day or night
  • Inactive Ingredients

    Carpylic/Capric Triglyceride(Coconut), Coco-Caprlyate (Coconut), Microcrystalline Wax, Parrafin Wax, Euphorbia Cerifera (Candililla) Wax, C10-C30 Cholesterol/Lanosterol Esters, Ceramide 3, Phytosphingosine, Isostearyl Isostearate, Glycyrrhetinic Acid(Licorice Root)

  • PRINCIPAL DISPLAY PANEL

    TrueLipids TrueLips Lip Balm

  • INGREDIENTS AND APPEARANCE
    WHITE PETROLATUM 
    cheryllee md sensitive skin care truelipids truelips lip balm ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61387-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ENOXOLONE (UNII: P540XA09DR)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61387-250-021 in 1 CARTON03/01/2014
    1NDC:61387-250-0115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01503/01/2014
    Labeler - Claridei Laboratories, Inc. (035627639)
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