Label: LANSINOH ANTI-ITCH- menthol 0.5% cream

  • NDC Code(s): 53997-002-01, 53997-002-02
  • Packager: Lansinoh Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 24, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Menthol 0.5%Topical Analgesic

  • ASK DOCTOR

    Stop Use and ask a doctor

    • if condition worsens
    • if symptoms persist for more than 7 days
    • Or if symptoms clear up and occur again withina few days
  • ASK DOCTOR/PHARMACIST

  • DO NOT USE

    Do NOT use in or near mouth, or on breasts or nipples when breast feeding.

    Pregnant women are advised to consult their physician before using any OTC drug product.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison Control Center right awau (1-800-222-1222)

  • PURPOSE

    For temporary relief of itching

  • QUESTIONS

  • STOP USE

    Stop use and ask a doctor

    • If condition worsens
    • If symptoms persists for more than 7 days
    • Or if symptoms clear up and occur again within a few days
  • WARNINGS

    Warnings

    For external use only

    Avoid contact withthe eyes

  • DOSAGE & ADMINISTRATION

    Directions

    • For adults and children 2 years and older
    • Apply externally to the affected area, no more than 3-4 times daily
  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Aloe Barbadensis Leaf Juice, Avena Sativa (Oat) Meal Extract, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cucumis Sativus Fruit Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, Hyaluronic Acid, Hydrolyzed Jojoba Esters, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Palmitate, Polysorbate 60, Prunus Armeniaca (Apricot) Kernel Oil), Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Potassium Sorbate, Sodium Chloride, Sodium Hydroxide, Sorbitan Isostearate, 1,2-Hexanediol, Sorbitan Olivate, Squalane, Water (Eau, Aqua).

  • INDICATIONS & USAGE

    Uses
    For temporary relief of itching

  • PRINCIPAL DISPLAY PANEL

    Drug fact and front

    front

    Display cartoon

  • INGREDIENTS AND APPEARANCE
    LANSINOH ANTI-ITCH 
    menthol 0.5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53997-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CUCUMBER (UNII: YY7C30VXJT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SQUALANE (UNII: GW89575KF9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    WATER (UNII: 059QF0KO0R)  
    HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS) (UNII: CH428W5O62)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    OATMEAL (UNII: 8PI54V663Y)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53997-002-021 in 1 CARTON05/15/2024
    1NDC:53997-002-01125 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/15/2024
    Labeler - Lansinoh Laboratories Inc (181696907)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Pharmaceuticals Laboratories, LLC116933772manufacture(53997-002)