Label: ECZEMA RELIEF CREAM- colloidal oatmeal 1% cream

  • 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 March 17, 2021

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  • Active ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Colloidal Oatmeal 1%...Skin Protectant

  • Uses

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

    • eczema
    • poison ivy, oak or sumac
    • insect bites
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breastfeeding, ask a health professional before use.

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

  • Directions

    Apply as needed.

  • Other information

    • Store in a cool dry place away from light
  • Inactive ingredients

    water (aqua), coco-caprylate, organic shea (butyrospermum parkii) butter, organic jojoba (simmondsia chinensis) seed oil, glycerin, methylsulfonylmethane (MSM), cetearyl alcohol, cetearyl olivate, organic hemp (cannabis sativa) aerial part extract, organic hemp (cannabis sativa) seed oil, sorbitan olivate, organic aloe (aloe barbadensis) leaf juice, cetearyl glucoside, ethylhexylglycerin, glucose,

    allantoin, xanthan gum, linalool, limonene, lactoperoxidase, glucose oxidase, organic lavender (lavandula angustifolia) oil, black pepper (piper nigrum) fruit oil, clove (syzygium aromaticum) flower oil, organic geranium (pelargonium graveolens) flower oi


  • Questions or comments?

    Call 877-669-4367 Monday through Friday, 9am-5pm EST.

  • Principal Display Panel

    HempFusion

    Eczema

    Relief

    CREAM

    Colloidal Oatmeal 1%

    Including nourishing Aloe Vera, hemp extract with naturally occuring CBD (100mg/bottle) + Terpenes (60mg/bottle) from black pepper and clove & other natural skin moisturizers

    U.S. Hemp Authority H Certified

    NON-GMO

    ALL SKIN TYPES

    50mL (1.69 fl oz)

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    ECZEMA RELIEF CREAM 
    colloidal oatmeal 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73672-983
    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
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ALOE (UNII: V5VD430YW9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    MYELOPEROXIDASE (UNII: JQZ6YM58U5)  
    GLUCOSE OXIDASE (UNII: 0T8392U5N1)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    HEMP (UNII: TD1MUT01Q7)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BLACK PEPPER OIL (UNII: U17J84S19Z)  
    CLOVE OIL (UNII: 578389D6D0)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73672-983-501 in 1 CARTON02/10/2020
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/10/2020
    Labeler - HEMPFUSION, INC. (117152485)
    Establishment
    NameAddressID/FEIBusiness Operations
    Universal Packaging Systems, Inc. (DBA Paklab) 177711082manufacture(73672-983)
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