Label: ECZEMA SPOT TREATMENT SKIN PROTECTANT- oatmeal lotion

  • NDC Code(s): 59062-1743-1
  • Packager: KAS Direct LLC dba BabyGanics
  • 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 July 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal oatmeal 5%

  • Purpose

    Skin protectant

  • Uses

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

    • rashes
    • eczema
  • 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 to affected areas
    • for larger or full body coverage, use Babyganics Eczema Cream
  • Other information

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

    helianthus annuus (sunflower) seed oil1, tapioca starch, castor oil/IPDI copolymer, cocos nucifera (coconut) oil1, butyrospermum parkii (shea) butter1, caprylic/capric triglyceride, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed oil1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, tocopherol

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

    dist. by KAS direct, LLC
    1600 Stewart Avenue
    Westbury, NY 11590

  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

    babyganics

    ACCEPTED
    NATIONALECZEMA.ORG
    NATIONAL
    ECZEMA
    ASSOCIATION

    eczema
    spot
    treatment

    skin
    protectant

    fragrance free
    helps to relieve
    dry, itchy, irritated
    skin ∙ non-allergenic
    pediatrician &
    dermatologist tested

    Discover which of
    our ingredients are
    Certified Organic
    on back of carton.

    Net wt 1 OZ (28.35 g)

    PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ECZEMA SPOT TREATMENT   SKIN PROTECTANT
    oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1743
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    Nigella Sativa Seed Oil (UNII: CS4U38E731)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-1743-11 in 1 BOX03/15/2019
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34703/15/2019
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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