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
  • Marketing Status: OTC monograph not 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 February 14, 2017

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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 not finalpart34803/01/2017
    Labeler - Ferndale Laboratories, Inc. (005320536)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ferndale Laboratories, Inc.005320536manufacture(0496-0586)
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