Label: ALL OVER- colloidal oatmeal ointment

  • NDC Code(s): 73088-302-02, 73088-302-08, 73088-302-35
  • Packager: Tubby Todd
  • 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 February 8, 2023

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  • 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 use near eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens.
    • symptoms may 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 swollowed, seek medical advice or contact a Poison Control Center immediately.

  • Directions

    • Apply as needed
  • Other Information

    • Do not use if quality seal is broken or missing
    • Protect from excessive heat (40°C/104°F)
  • Inactive ingredients

    Lavender and Rosemary: Beeswax, Camellia Sinensis Leaf Extract*, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract*, Fragrance**, Glycerin, Jojoba Esters, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida (Lavandin) Oil, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Fruit Extract*, Persea Gratissima (Avocado) Fruit Extract*, Propanediol, Saccharomyces Ferment Filtrate, Stearic Acid, Stearyl Alcohol, Water

    *Organic ingredient

    **Comprised of natural, aromatic, raw materials

  • Questions or comments?

    Call us at (619) 894-6560

  • PRINCIPAL DISPLAY PANEL

    AOO 2oz-preview

  • INGREDIENTS AND APPEARANCE
    ALL OVER 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73088-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
    AVOCADO (UNII: SDS87L369F)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    MANGO JUICE (UNII: IU6I1JNV24)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73088-302-0257 g in 1 TUBE; Type 0: Not a Combination Product04/20/2021
    2NDC:73088-302-3599 g in 1 JAR; Type 0: Not a Combination Product04/20/2021
    3NDC:73088-302-08227 g in 1 JAR; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/20/2021
    Labeler - Tubby Todd (052545299)
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