Aveeno Baby Eczema Therapy Soothing Bath Treatment: Package Insert and Label Information

AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT- oatmeal powder
Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

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 Facts

Active ingredient

Colloidal Oatmeal (43%)

Purpose

Skin Protectant

Uses

Temporary 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 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?

855-4AVEENO; outside US dial collect 215-273-8755 or visit www.aveeno.com

Distributed in the US by:
JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY
Division of Johnson & Johnson Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL — 5 Pouch Carton

PEDIATRICIAN RECOMMENDED

Aveeno®
Baby®

Eczema
Therapy
SOOTHING
BATH TREATMENT
colloidal oatmeal skin protectant
Fragrance Free, Tear-Free
Relieves Dry, Itchy, Irritated skin due to:
Rashes, Eczema, Poison Ivy/Oak/Sumac, Insect Bites
National Eczema
Association
ACCEPTED

Nationaleczema.org

5 Bath Packets TOTAL NET WT. 3.75 OZ. (105g)

same great product. new name!

Principal Display Panel -- 5 Pouch Carton
(click image for full-size original)
AVEENO BABY ECZEMA THERAPY SOOTHING BATH TREATMENT
oatmeal powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58232-0018
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oatmeal (Oatmeal) Oatmeal 430 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Mineral Oil
Calcium Silicate
Laureth-4
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58232-0018-1 21 g in 1 POUCH None
2 NDC:58232-0018-2 5 POUCH (POUCH) in 1 CARTON contains a POUCH
2 21 g in 1 POUCH This package is contained within the CARTON (58232-0018-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 11/28/2011
Labeler — Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc. (830803164)

Revised: 11/2011 Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.

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