Label: SOOTHING ITCH SKIN PROTECTANT- oatmeal stick

  • 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 January 15, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal oatmeal 10%

  • Purpose

    Skin protectant

  • Uses

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

    • insect bites
    • rashes
    • poison ivy, oak or sumac
  • 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

    • store at room temperature 59-77°F (15-25°C)
    • keep carton for complete information
  • Inactive ingredients

    helianthus annuus (sunflower) seed oil1, cera alba (beeswax)1, cocos nucifera (coconut) oil1, ricinus communis (castor) seed oil1, butyrospermum parkii (shea) butter1, calendula officinalis (calendula) flower oil1, mentha piperita (peppermint) oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, solanum lycopersicum (tomato) seed oil, tocopherol, lavandula angustifolia (lavender) oil, anthemis nobilis (chamomile) oil

    1
    Certified Organic Ingredient. Unless otherwise specified product not labeled as organic.
  • SPL UNCLASSIFIED SECTION

    dist. by KAS Direct, LLC
    San Francisco, CA
    94111

  • PRINCIPAL DISPLAY PANEL - 18 g Applicator Carton

    babyganics®

    soothing
    itch stick

    skin protectant

    colloidal oatmeal* helps
    relieve irritation caused by
    insect bites & rashes

    made without parabens,
    phthalates, cortisone, steroids,
    dyes, fragrances

    Discover which of our ingredients are
    certified organic on the back panel.

    NET WT 0.64 OZ (18 g)

    PRINCIPAL DISPLAY PANEL - 18 g Applicator Carton
  • INGREDIENTS AND APPEARANCE
    SOOTHING ITCH   SKIN PROTECTANT
    oatmeal stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-3300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    oatmeal (UNII: 8PI54V663Y) (oatmeal - UNII:8PI54V663Y) oatmeal100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-3300-11 in 1 CARTON02/15/2021
    118 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34702/15/2021
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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