Label: DERMEND MOISTURIZING ANTI-ITCH- pramoxine hydrochloride lotion

  • NDC Code(s): 0496-0586-08
  • Packager: Ferndale Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredient

    Pramoxine HCl 1% w/w

  • Purpose

    external analgesic

  • Use

    for the temporary relief of itching associated with minor skin irritations

  • Warnings

    For external use only.

    Avoid contact with the eyes.

    Stop use and ask a doctor if

    • conditions 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, seek medical attention or contact a Poison Cotrol Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    cetyl alcohol, di-isopropyl adipate, dimethicone, glycerin, FORLAN-L (Contains: petrolatum, lanolin, hydrogenated coconut oil, sorbitan sesquioleate, stearyl alcohol, and cetyl alcohol), mineral oil, polyoxyl 40 stearate, potassium sorbate, povidone, purified water, sorbic acid, stearic acid, and trolamine

  • Package Label

    NDC 0496-0586-08

    8oz (237mL)

    DerMendBottleLabel

  • INGREDIENTS AND APPEARANCE
    DERMEND MOISTURIZING ANTI-ITCH 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0586
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POVIDONE (UNII: FZ989GH94E)  
    WATER (UNII: 059QF0KO0R)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0496-0586-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2017
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0586)
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