Label: ECZEMA- colloidal oatmeal cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • Drug Facts Active Ingredient

    Colloidal Oatmeal 2.0%

  • 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 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days,, discontinue use of this product and consult a doctor.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 5 years and over apply gently to the affected area as needed. Not recommended for face.

  • Other information

    Protect from excessive heat

    Store at 20-25 oC (68-77F)

  • Inactive Ingredients

    Arnica montana flower extract, cetyl palmitate, ethylhexylglycerin, eucalyptus (Eucalyptus cinerea), glycerin, glyceryl stearate, jojoba (Buxus chinensis) oil, peppermint (mentha piperita) oil, phenoxyethanol, rosemary (Rosmariunus officinalis) oil, sodium citrate, stearic acid, sweet almond (Prunus amydgalus dulcis) oil, tea tree (Melaleuca alternifolia) oil, tocopherol (Vitamin E), water

  • Questions?

    Call (866) 419-3567

    Monday through Friday 8:00am - 2:00pm ET

  • SPL UNCLASSIFIED SECTION

    Tamper evident: Do not use if safety seal under cap is broken or missing.

    Manufactured for Smith Amish LLC 16350 N Hwy 329 Reddick, FL 32634

  • Label

    Smith Amish Eczema Cream (72609-704-02)

    Deep Moisturizing Cream

    for sensitive, distressed, dry, scaly skin

    Clean Fresh Scent

    Easily Absorbed and Non-Greasy

    Net wt. 2oz (59g)

    labels

  • INGREDIENTS AND APPEARANCE
    ECZEMA 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72609-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72609-704-021 in 1 BOX08/28/2024
    159 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/28/2024
    Labeler - Smith Amish, LLC (081504527)
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