Label: EUCERIN ITCH RELIEF INTENSIVE CALMING- menthol lotion

  • NDC Code(s): 10356-358-29, 10356-358-51
  • Packager: Beiersdorf 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 December 30, 2022

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  • ACTIVE INGREDIENT

    Menthol 0.1%

  • PURPOSE

    External analgesic lotion

  • INDICATIONS & USAGE

    Use for the temporary relief of itching associated with minor skin irritations.

  • WARNINGS

    For external use only.

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

    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
    • irritation occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • QUESTIONS

    Questions or comments 1 800 227 4703

  • INACTIVE INGREDIENT

    Ingredients:

    Water, Glycerin, Alcohol Denat., Hydrogenated Coco-Glycerides, Isopropyl Palmitate, Triisostearin,
    Stearyl Alcohol, Laureth-9, Palmitic Acid, Stearic Acid, Distarch Phosphate, Dimethicone,
    Glyceryl Stearate, Cetyl Alcohol, PEG-100 Stearate, Sorbitan Stearate, Arginine HCl, Tocopherol,
    Ceramide NP, Sodium Citrate, Citric Acid, Myristic Acid, Arachidic Acid, Oleic Acid,
    Benzyl Alcohol, Pentylene Glycol, Ethylhexylglycerin, 4-t-butylcyclohexanol,
    Menthoxypropanediol, Carbomer, Sodium Hydroxide, Trisodium EDTA.Inactive Ingredients

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 8 years of age and older

    • apply to affected area not more than 3 to 4 times daily

    Children under 8 years of age

    • consult a doctor
  • PRINCIPAL DISPLAY PANEL

    Eucerin

    Itch Relief Intensive Calming Lotion

    Dry, Itchy Skin

    up to 12 hours itch relief

    Immediately relieves and calms dry, itchy skin

    Menthol External Analgesic Lotion

    Soothing, cooling effect

    Ceramide enriched

    Fragrance and Dye Free

    Dermatological skincare

    eucintcalmitchlotionfrontlabel

    eucintcalmlotionbacklabel

  • INGREDIENTS AND APPEARANCE
    EUCERIN ITCH RELIEF INTENSIVE CALMING 
    menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10356-358
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CARBOMER 980 (UNII: 4Q93RCW27E)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE NP (UNII: 4370DF050B)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    ARACHIDIC ACID (UNII: PQB8MJD4RB)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    TRIISOSTEARIN (UNII: 71503RH8KG)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10356-358-51250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    2NDC:10356-358-2914 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2020
    Labeler - Beiersdorf Inc (001177906)
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