Aveeno Baby Eczema Therapy Soothing Bath Treatment Powder
FDA Label NDC 69968-0541

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Aveeno Baby Eczema Therapy Soothing Bath Treatment (NDC 69968-0541). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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.

Otc - Keep Out Of Reach Of Children

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

Principal Display Panel - 213 G Packet Carton

PEDIATRICIAN RECOMMENDED BRAND
Aveeno
Baby®
Eczema
Therapy
SOOTHING
BATH TREATMENT
colloidal oatmeal skin protectant
Steroid-free, Fragrance free, Paraben-free, Phthalate-free
Relieves Dry, Itchy, Irritated skin due to:
Rashes, Eczema, Poison Ivy/Oak/Sumac, Insect Bites
National
Eczema
Association
ACCEPTED
NATIONALECZEMA.ORG

10 Bath Packets
TOTAL NET WT. 7.5 OZ. (213 g)

Principal Display Panel (213 g Packet Carton)

Principal Display Panel (213 g Packet Carton)

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