Label: AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT- oatmeal powder

  • NDC Code(s): 69968-0541-1, 69968-0541-3
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 May 2, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal oatmeal 43%

  • Purpose

    Skin protectant

  • Uses

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

    • Rashes
    • Eczema
    • Poison ivy, oak or sumac
    • Insect bites
  • Warnings

    For external use only.

    When using this product

    • Do not get into eyes.
    • To avoid slipping, use mat in tub or shower.
    • In some skin conditions, soaking too long may overdry.

    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

    For dispersal in water:

    • Turn warm water faucet on to full force.
    • Slowly sprinkle packet of colloidal oatmeal directly under the faucet into the tub or container.
    • Stir any colloidal oatmeal settled on the bottom.

    For use as a soak in a bath:

    • Slowly sprinkle one packet in an infant tub filled with warm water. Stir any colloidal oatmeal that may have settled on the bottom.
    • Soak affected area for 15 to 30 minutes as needed, or as directed by a doctor.
    • Pat dry (do not rub) to keep a thin layer on the skin.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    Mineral Oil, Calcium Silicate, Laureth-4

  • Questions?

    866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 213 g Packet Carton

    RECOMMENDED BY
    PEDIATRICIANS
    & DERMATOLOGISTS

    Aveeno ®

    baby

    NEW

    LOOK
    Same Great
    Formula

    eczema
    therapy

    soothing bath treatment

    colloidal oatmeal
    skin protectant

    relieves dry, itchy,
    irritated skin due to:
    eczema, rashes,
    poison ivy/oak/sumac,
    insect bites

    fragrance-free, allergy tested,
    tear-free, steroid free

    ACCEPTED
    NATIONALECZEMA.ORG

    National
    Eczema
    Association

    10 Bath Packets

    TOTAL NET WT. 7.5 OZ. (213 g)

    PRINCIPAL DISPLAY PANEL - 213 g Packet Carton
  • INGREDIENTS AND APPEARANCE
    AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT 
    oatmeal powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0541
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL430 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    LAURETH-4 (UNII: 6HQ855798J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0541-110 in 1 CARTON03/25/201905/01/2025
    121 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69968-0541-35 in 1 CARTON01/01/2012
    221 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2012
    Labeler - Johnson & Johnson Consumer Inc. (118772437)