Label: CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING- pramoxine hydrochloride cream

  • NDC Code(s): 49967-512-01, 49967-512-02, 49967-512-03
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

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  • Active ingredient

    Pramoxine hydrochloride 1%

  • Purpose

    External analgesic

  • Use

    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 last 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.

  • WHEN USING

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • 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


    water, glycerin, petrolatum, cetyl alcohol, butyrospermum parkii (shea) butter, cetearyl alcohol, PEG-100 stearate, glyceryl stearate, isopropyl myristate, stearic acid, dimethicone, palmitic acid, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, behentrimonium methosulfate, sodium hydroxide, myristic acid, sodium lauroyl lactylate, cholesterol, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., hydrolyzed hyaluronic acid, citric acid, xanthan gum, hytosphingosine, ethylhexylglycerin

  • Questions or comments?

    Toll-Free Number 888-768-2915

  • PRINCIPAL DISPLAY PANEL

    image of a front label

    image of a front label
  • PRINCIPAL DISPLAY PANEL

    image of a back label

    image of a back label
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING 
    pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-512
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
    TASMANNIA LANCEOLATA FRUIT (UNII: PNT2HDL13Q)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-512-01340 g in 1 JAR; Type 0: Not a Combination Product09/18/2017
    2NDC:49967-512-02453.6 g in 1 JAR; Type 0: Not a Combination Product09/18/2017
    3NDC:49967-512-03538.6 g in 1 JAR; Type 0: Not a Combination Product09/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/18/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, Inc.071609663MANUFACTURE(49967-512)
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