Label: PIPETTE ECZEMA- oatmeal liquid

  • 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 June 6, 2022

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  • Drug Facts

  • Active Ingredients

    Colloidal Oatmeal 1 %

    Purpose

    Skin protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to: 

    • eczema • rashes

  • 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

    Keep out of reach of children.

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

    • apply as needed
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Water, Squalane, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Sunflower Seed Oil Polyglyceryl-3 Esters, Hydroxystearic/Linolenic/Oleic Polyglycerides, Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Ceramide NP, Tocopherol, Sodium Phytate, Hydrogenated Sunflower Seed Oil, Glyceryl Esters, Cetearyl Alcohol, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, Xanthan Gum, Ethylhexylglycerin, Potassium Sorbate, Citric Acid.

  • Questions or comments?

    Call 855-747-2229

  • Package Labeling:73517-001-01

    Outer Package

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    Inner Package

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  • Package Labeling:73517-001-06

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    PIPETTE ECZEMA 
    oatmeal liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CERAMIDE NP (UNII: 4370DF050B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73517-001-011 in 1 BOX05/16/2022
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:73517-001-061 in 1 BOX05/16/2022
    2177 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/16/2022
    Labeler - Amyris, Inc (185930182)
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