Label: VASELINE- clinical care eczema calming therapy cream lotion

  • NDC Code(s): 64942-1867-1
  • Packager: Conopco, Inc. d/b/a/ Unilever
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 7, 2022

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  • Description

    VASELINE CLINICAL CARE ECZEMA CALMING THERAPY CREAM - (colloidal oatmeal) lotion

  • Drug Facts

    Active ingredient
    Colloidal Oatmeal (1%)

  • Purpose

    Skin Protectant

  • Uses

    temporarily protects and helps relieve minor skin irritation and itching due to: eczema

  • Warnings

    For external use only
    When using this product     do not get into eyes. If contact occurs, rinse thoroughly with water.
    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
  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults, adolescents, and children over 6 months of age: Apply to affected area as needed

  • Inactive ingredients

    Water (Eau), Petrolatum, Glycerin, Stearic Acid, Glycol Stearate, Isopropyl Palmitate, Dimethicone, Triethanolamine, Glyceryl Stearate, Isopropyl Myristate, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Phenoxyethanol, Methylparaben, Magnesium Aluminum Silicate, Carbomer, Propylparaben, Stearamide AMP, Disodium EDTA, Hydroxystearic Acid.

  • Questions or comments?

    1-800-457-7084

  • Packaging

    Vaseline Eczema Therapy Cream

  • INGREDIENTS AND APPEARANCE
    VASELINE 
    clinical care eczema calming therapy cream lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1867
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARAMIDE AMP (UNII: U3K8640346)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64942-1867-1200 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/05/2021
    Labeler - Conopco, Inc. d/b/a/ Unilever (001375088)
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