Label: LANSINOH PAIN RELIEVING- lidocaine hcl spray

  • NDC Code(s): 53997-001-01, 53997-001-02
  • Packager: Lansinoh Laboratories Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 22, 2024

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  • DRUG FACTS

    Active IngredientPurpose
    Lidocaine 4%Topical Analgesic

  • STOP USE AND ASK A DOCTOR

    Stop use and ask a doctor if
    ■ Condition worsens
    ■ Symptoms persist for more than 7 days
    ■ Symptoms clear up and return within a
    few day

  • ASK DOCTOR/PHARMACIST

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. Do
    not use on infants or children under 12.

  • WARNINGS


    Warnings
    For external use only.
    Do NOT use on breasts, nipples, in or
    near mouth.
    KEEP OUT OF REACH OF CHILDREN. Do
    not use on infants or children under 12.
    If swallowed, get medical help or contact
    a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if
    ■ Condition worsens
    ■ Symptoms persist for more than 7 days
    ■ Symptoms clear up and return within a
    few days

  • DOSAGE & ADMINISTRATION

    Directions ■ For adult use only
    ■ Apply externally to the affected area not more than 3 - 4 times in a 24 hour period.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Alcohol (Ethanol), Aloe Barbadensis Leaf Juice, Cellulose Gum, Eugenol, Hamamelis Virginiana (Witch Hazel) Water, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, PEG-40 Hydrogenated Castor Oil, Poloxamer 188, Potassium Sorbate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sodium Benzoate, Sodium Phytate, Water.

    Distributed By: Lansinoh Laboratories, Inc
    Alexandria, VA 22314, USA
    Tel: +1-800-292-4794 | www.lansinoh.com

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • INDICATIONS & USAGE

    For external use only

  • PURPOSE

    Topical Analgesic

  • PRINCIPAL DISPLAY PANEL

    Lidocaine CartonLidocaine Label

  • INGREDIENTS AND APPEARANCE
    LANSINOH PAIN RELIEVING 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53997-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    EUGENOL (UNII: 3T8H1794QW)  
    ALCOHOL (UNII: 3K9958V90M)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 2300 MPA.S AT 1%) (UNII: 0Z2R7OG99L)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53997-001-021 in 1 CARTON02/15/2021
    1NDC:53997-001-01100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/15/2021
    Labeler - Lansinoh Laboratories Inc (181696907)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Pharmaceuticals Laboratories LLC116933772manufacture(53997-001)
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