Label: MAYBELLINE NEW YORK BABY LIPS DR RESCUE MEDICATED BALM- menthol lipstick

  • NDC Code(s): 49967-489-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • Active Ingredient

    Menthol 0.5%

  • Purpose

    External analgesic

  • Use

    for the temporary relief of pain associated with fever blisters and cold sores

  • 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

  • Keep out of reach of children.

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

  • Directions

    for adult use only: apply to affected area not more than 3 to 4 times daily

  • Inactive ingredients

    octyldodecanol, polybutene, petrolatum, isopropyl myristate, polyethylene, ozokerite, diisostearyl malate, butyrospermum parkii (shea) butter, euphorbia cerifera (candelilla) wax, VP/hexadecene copolymer, eucalyptus globulus leaf oil, penaerythrityl tetra-di-t-butyl hydroxyhydrocinamate, tocopherol, tocopheryl acetate, limonene, honey, centella asiatica extract

  • Questions or comments?

    1-800-322-2036 Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a label

    image of a label
  • INGREDIENTS AND APPEARANCE
    MAYBELLINE NEW YORK BABY LIPS DR RESCUE MEDICATED BALM 
    menthol lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-489
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-489-011 in 1 BLISTER PACK10/01/2013
    14.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2013
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.624244349manufacture(49967-489)
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