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

  • NDC Code(s): 49967-970-01, 49967-970-02, 49967-970-03, 49967-970-04
  • 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.

  • 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, isopropyl myristate, PEG-100 stearate, glyceryl stearate, cetearyl alcohol, cetyl alcohol, glycerin, niacinamide, dimethicone, stearic acid, allantoin, potassium phosphate, ceramide NP, ceramide AP, ceramide EOP, carbomer, zinc citrate, behentrimonium methosulfate, sodium hydroxide, sodium lauroyl lactylate, arginine PCA, myristic acid, sodium PCA, cholesterol, palmitic acid, tasmannia lanceolata fruit extract, phenoxyethanol, dipotassium phosphate, disodium EDTA, alcohol denat., tocopheryl acetate, hydrolyzed hyaluronic acid, xanthan gum, phytosphingosine, polyglyceryl-3 diisostearate, ethylhexylglycerin

  • Questions?

    Toll-Free Number 888-768-2915

    www.cerave.com

  • PRINCIPAL DISPLAY PANEL

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    image of a front label
  • PRINCIPAL DISPLAY PANEL

    image of a back labelimage of a back label

    image of a back label
  • INGREDIENTS AND APPEARANCE
    CERAVE DEVELOPED WITH DERMATOLOGISTS ITCH RELIEF MOISTURIZING 
    pramoxine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-970
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    ARGININE PYROGLUTAMATE (UNII: 808T94CEU6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-970-01237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/17/2017
    2NDC:49967-970-0215 in 1 TRAY08/17/2017
    229.6 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49967-970-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    4NDC:49967-970-04562 mL in 1 BOTTLE; Type 0: Not a Combination Product08/17/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/17/2017
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'OREAL USA PRODUCTS, INC624244349manufacture(49967-970) , pack(49967-970)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.960317444manufacture(49967-970) , pack(49967-970)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac, LLC061595175manufacture(49967-970)
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