Label: LORNAMEAD LYPSYL- petrolatum paste

  • 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 March 6, 2013

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  • Active ingredients

    Petrolatum 62% ......................................................... Skin Protectant

    Menthol 0.6% .............................................................External Analgesic

  • Uses

    • For the temporary relief of pain & itching associated with cold sores and fever blisters
    • Temporarily protects and helps relieve chapped or cracked lips
  • WARNINGS

    For External Use Only. When using this product do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention. Stop use and ask a doctor if condition worsens or if symptoms persist for 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.

  • Directions

    Adults and children 12 years of age and older: Apply directly to cold sore or fever blister 1 to 3 times daily

    Children under 2 years of age: Consult a doctor 

  • DOSAGE & ADMINISTRATION

    Apply directly to cold sore or fever blister 1 to 3 times daily Children under 2 years of age: ask a doctor

  • Other Information

    Store between 15 - 30C (59-86F)

  • Inactive ingredients

    Beeswax, Polyisobutene, Hydrogenatede Polyisobutene, Ethylene/Propylene/Styrene Copolymer, Butylene/Ethylene/Styrene Copolymer, Pentaerythrityl Tetracaprylate/Tetracaprate, Eucalyptus Globulus Leaf Extract, Melaleuca Alternifolia (Tea Tree) Extract, Ceretified Organic Butyrospermum Parkii (Shea Butter) Fruit, Aloe Barbadensis Leaf Extract, Lysine, Dimethicone, Allantoin, Tocopheryl Acetate (Vitamin E Acetate), Bisabolol, Chamomilla Recutita (Matricaria) Extract, Lavandula Angustifolia (Lavender) Extract, Mentha Piperita (Peppermint) Oil, Camphor, Zinc Lactate, Ascorbyl Palmitate, Propolis Extract, Helianthus Annuus (Sunflower) Seed Extract, Propylparaben, Titanium Dioxide

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    LORNAMEAD  LYPSYL
    petrolatum paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62721-8114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM65.004 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PENTAERYTHRITYL TETRACAPRYLATE/TETRACAPRATE (UNII: 832C4KF14X)  
    POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    LYSINE (UNII: K3Z4F929H6)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62721-8114-91 in 1 CARTON
    1NDC:62721-8114-28 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/01/2012
    Labeler - Lornamead (126440440)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead126440440manufacture(62721-8114) , pack(62721-8114)
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