Label: PRAMOXINE ITCH RELIEF- pramoxine hcl 1% cream

  • 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 April 25, 2023

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  • ACTIVE INGREDIENT

    Pramoxine Hydrochloride 1%

  • PURPOSE

    External Analgesic

  • INDICATIONS & USAGE

    For the temporary relief of itching associated with minor skin irritations

  • WARNINGS

    For external use only

    When using this product, do not get into eyes

    Stop use and ask a doctor if

    • Condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    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 INGREDIENT

    Aloe Vera, Behenic Acid, Cetearyl Alcohol, Cetyl Alcohol, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate, Petrolatum, Phenoxyethanol, Phystosphingosine, Polyglyceryl- 6 Behenate, Polyglyceryl-10 Stearate, Potassium Sorbate, Shea butter, Sodium Cetearyl Sulfate, Sodium Levulinate, Stearic Acid, Triethanolamine, Triethyl Citrate, Water, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    PRAMOXINE ITCH RELIEF 
    pramoxine hcl 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-141-12340 g in 1 JAR; Type 0: Not a Combination Product04/25/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/25/2023
    Labeler - CVS (062312574)
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