Label: CALMING ITCH AND IRRITATION- colloidal oatmeal lotion

  • NDC Code(s): 54136-322-81
  • Packager: Better Planet Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Active Ingredients

    Active ingredients Purpose

    Colloidal Oatmeal 2.0%........... Skin Protectant

  • Purpose

    Purpose

    Skin Protectant

  • Uses

    Uses

    * Help prevent and temporarily protects chafed, chapped or cracked skin

  • Warnings

    Warnings For external use only.

  • WHEN USING

    When using the product * Do not get into eyes

  • Stop use and ask a doctor if

    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

  • Do not use on

    * Deep or puncture wounds * Animal bites * Serious burns

  • SAFETY TIP: Keep out of reach of children.

    SAFETY TIP: Keep out of reach of children.

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

  • Directions

    Directions

    * Apply liberally or as needed. Do not use if quality seal is broken

  • Other information

    Other information

    * Remove quality seal. Do not use if quality seal is broken. Store at room temperature.

  • Inactive Ingredients

    Inactive Ingredients ALOE BARBADENSIS LEAF JUICE*; CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, WATER, COCOGLYCERIDES, GLYCERYL STEARATE SE, THEOBROMA CACAO (COCOA) SEED BUTTER, LIMNANTHES ALBA (MEADOWFOAM) SEED OIL GLYCERIN, CETEARYL OLIVATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SORBITAN OLIVATE, OLEA EUROPAEA (OLIVE) FRUIT OIL, GLYCERYL LAURATE, TOCOPHEROL, LAVANDULA ANGUSTIFOLIA
    (LAVENDER) OIL, HIPPOPHAE RHAMNOIDES SEED OIL, XANTHAN GUM, SQUALANE, SODIUM LEVULINATE, POTASSIUM SORBATE.

  • Questions?

    Questions? Call toll-free 877.902.2873

  • PRINCIPAL DISPLAY PANEL

    Calming Lotion Label

  • INGREDIENTS AND APPEARANCE
    CALMING ITCH AND IRRITATION 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54136-322
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    SQUALANE (UNII: GW89575KF9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54136-322-81239 g in 1 TUBE; Type 0: Not a Combination Product05/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/11/2020
    Labeler - Better Planet Brands LLC (960253719)
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